AzTrials
AzTrials

Biliary AtresiaBILACONCT05399745

BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease

An observational study of Biliary Atresia and Cognitive Impairment, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Biliary atresia is the most severe form of cholestatic liver disease. The children have high morbidity and mortality and get devastating pruritus and fatigue, failure to thrive, progressive hepatic failure and impaired neurodevelopment. The etiology is mostly unknown. Read more about this study

Who is it for?
Ages 0 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Biliary Atresia, Cognitive Impairment
What is being tested?
Neurocognitive monitoring
How many people
100 participants
Where
1 siteDenmark
Study dates
1 Mar 2020to 31 Dec 2040
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Children with biliary atresia (BA), children with Tetralogy of Fallot (ToF) and healthy control children between the age of 0-17 years. The BA and ToF children were recruited from their respective outpatient clinics at Rigshospitalet, Denmark, which is the only centre treating these patients. Healthy controls were siblings to BA children, recruited from staffs children and friends or recruited from a general practitioners office in Nivaa, Denmark. The recruitment took place from March 2020 and is ongoing

Who may be able to join

  • Biliary atresia
  • Tetralogy of Fallot
  • Healthy controls

Who cannot join

  • Not able to participate in exams

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vibeke Brix Christensen, MD, PhD, DMSc contact

+4535458842

vibeke.brix.christensen@regionh.dk

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Vibeke Brix Christensen, MD, PhD, DMSc, +4535458842, vibeke.brix.christensen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease With High Mortality, Compromised Neurological Development, Severe Malnutrition and Unknown Etiology

Biliary atresia is the most severe form of cholestatic liver disease. The children have high morbidity and mortality and get devastating pruritus and fatigue, failure to thrive, progressive hepatic failure and impaired neurodevelopment. The etiology is mostly unknown. More than half need a new liver from a living or deceased donor during childhood. However, correct timing of the transplantation is extremely difficult because of lack of consensus based on clinical assessment tools. All though the incidence is low, the cost of this disease is tremendous from both a clinical and human perspective. So far, protocolized neurodevelopment tests, genetic profiling, precise malnutrition evaluation based on clinical appearance, biochemical markers and brain MRI-scans, body composition, immunological function, level of physical activity and optimal time of transplantation in cholestatic children are unknown.

The aim is to determine risk factors for neurocognitive impairment in children suffering from severe cholestasis in order to determine optimal time for liver transplantation from a brain perspective.

In a prospective study, the investigators will investigate risk factors related to brain-, heart-, gut- and immunological function in the Danish cohort. This cohort consists of 75 children aged 0-18 years. In addition, 30 aged and gender matched healthy and 20 tetra fallot children will serve as control groups. The children will undergo extensive and advanced liver function evaluation, genetic profiling, nutrition and immunological status, neuro-imaging and neurocognitive evaluation at time of diagnose, 2 years of age, pre-school, pre-teenage, and teenage. In case of a liver transplantation, additional neuro-cognitive tests will be performed

Being tested
Neurocognitive monitoring
Medical subject headings
Biliary Atresia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurocognitive monitoringOther

    Neurocognitive tests and MRI of the brain

Study groups in NCT05399745
Study groupRoleWhat they receive
Children with biliary atresiaNot described
Receives: Other: Neurocognitive monitoring
Children with Tetralogy of FallotNot described
Receives: Other: Neurocognitive monitoring
Healthy control childrenNot described
Receives: Other: Neurocognitive monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: Inclusion

  2. Neurocognitive status: Early movement repertoire (General movement)

    Neurocognitive test panel depending on age at inclusion

    % of patients with of abnormal movement assessed using early movement repertoire (GM) if inclusion at diagnosis. Early movement repertoire is a measurement tool where abnormal movement is identified.

    Measured: Inclusion

  3. Neurocognitive status: Alberta Infant Motor Scale

    Neurocognitive test panel depending on age at inclusion:

    Alberta Infant Motor Scale if inclusion at diagnosis

    Percentile, highest is the best

    Measured: Inclusion

  4. Neurocognitive status: Bayley Scales of Development III

    Neurocognitive test panel depending on age at inclusion:

    Bayley Scales of Development III if inclusion up to 2.5 years:

    From 0-200, highest is best

    Measured: Inclusion

  5. Neurocognitive status: WIPPSI

    Neurocognitive test panel depending on age at inclusion:

    WIPPSI if inclusion between 2.5-6 years:

    Wechsler Preschool and Primary Scale of Intelligence, from 41 to 160, highest is best

    Measured: Inclusion

  6. Neurocognitive status: ABC Movement

    Neurocognitive test panel depending on age at inclusion:

    ABC Movement if inclusion between 2.5-16 years

    Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Measured: Inclusion

  7. Neurocognitive status: WISC-IV

    Neurocognitive test panel depending on age at inclusion:

    WISC-IV if inclusion between 6-16 years

    Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Measured: Inclusion

  8. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Neurocognitive test panel depending on age at inclusion:

    Auditory Verbal Learning Test/ToMaL if inclusion between 6-18 years Mean 10 SD 3, highest is best

    Measured: Inclusion

  9. Neurocognitive status: TEA-Ch

    Neurocognitive test panel depending on age at inclusion:

    TEA-Ch if inclusion between 6-18 years

    Test of Everyday Attention for Children, normalized to z-score, highest is best

    Measured: Inclusion

  10. Neurocognitive status: BADS-C

    Neurocognitive test panel depending on age at inclusion:

    BADS-C if inclusion between 6-18 years Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Measured: Inclusion

  11. Neurocognitive status: Test of Visual Perceptual Skills

    Neurocognitive test panel depending on age at inclusion:

    Test of Visual Perceptual Skills if inclusion between 6-18 years

    Percentile, highest is best

    Measured: Inclusion

  12. Neurocognitive status: CANTAB

    Neurocognitive test panel depending on age at inclusion:

    CANTAB if inclusion between 6-18 years Cambridge Neuropsychological Test Automated Battery

    Measured: Inclusion

  13. Neurocognitive status: The Beery Visuo-Motor Integration test

    Neurocognitive test panel depending on age at inclusion:

    The Beery Visuo-Motor Integration test if inclusion between 6-18 years Mean of 100 and standard deviation of 15, highest is best

    Measured: Inclusion

  14. Neurocognitive status: WAIS IV

    Neurocognitive test panel depending on age at inclusion:

    WAIS IV if inclusion from 16 to 18 years Wechsler Adult Intelligence Scale, 40-160, highest is best

    Measured: Inclusion

  15. Neurocognitive status: Kiddie-sads

    Neurocognitive test panel depending on age at inclusion:

    Kiddie-sads if included between 2-18 years Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: Inclusion

  16. Neurocognitive status: BRIEF 1

    Neurocognitive test panel depending on age at inclusion:

    BRIEF 1 if inclusion up to 6 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: Inclusion

  17. Neurocognitive status: BRIEF 2

    Neurocognitive test panel depending on age at inclusion:

    BRIEF 2 if inclusion between 6-18 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: Inclusion

  18. Neurocognitive status: CBCL

    Neurocognitive test panel depending on age at inclusion:

    CBCL if included between 2-18 years Child Behavior Checklist, percentile, lowest is best

    Measured: Inclusion

  19. Neurocognitive status: ADHD screening

    Neurocognitive test panel depending on age at inclusion:

    ADHD screening if included between 2-18 years Lowest is best, 0-78

    Measured: Inclusion

  20. Neurocognitive status: SRS-2

    Neurocognitive test panel depending on age at inclusion:

    SRS-2 screening if included between 6-18 years

    Social Responsiveness Scale, 32-114. lowest is best

    Measured: Inclusion

  21. Neurocognitive status: Vineland

    Neurocognitive test panel depending on age at inclusion:

    Vineland screening if included between 6-18 years Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Measured: Inclusion

  22. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: 1 year

  23. Neurocognitive status: Alberta Infant Motor Scale

    Alberta Infant Motor Scale Percentile, highest is the best

    Measured: 1 year

  24. Neurocognitive status: Bayley Scales of Development III

    Bayley Scales of Development III

    From 0-200, highest is best

    Measured: 1 year

  25. Neurocognitive status: BRIEF 1

    BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: 1 year

  26. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Measured: 1 year

  27. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: 1 year

  28. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: 2 years

  29. Neurocognitive status: Bayley Scales of Development III

    Bayley Scales of Development III From 0-200, highest is best

    Measured: 2 years

  30. Neurocognitive status: BRIEF 1

    BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: 2 years

  31. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Measured: 2 years

  32. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: 2 years

  33. Neurocognitive status: ADHD

    ADHD Lowest is best, 0-78

    Measured: 2 years

  34. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Measured: 2 years

  35. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: 6 years

  36. Neurocognitive: Movement ABC

    Neurocognitive test panel depending on age Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Measured: 6 years

  37. Neurocognitive status: WISC-IV

    WISC-IV

    Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Measured: 6 years

  38. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Measured: 6 years

  39. Neurocognitive status: TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Measured: 6 years

  40. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Measured: 6 years

  41. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Measured: 6 years

  42. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Measured: 6 years

  43. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Measured: 6 years

  44. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: 6 years

  45. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Measured: 6 years

  46. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Measured: 6 years

  47. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: 6 years

  48. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Measured: 6 years

  49. Neurocognitive status: Vineland

    Vineland Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Measured: 6 years

  50. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: 11 years

  51. Neurocognitive status: Movement ABC

    Neurocognitive test panel depending on age at inclusion:

    ABC Movement if inclusion between 2.5-16 years

    Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Measured: 11 years

  52. Neurocognitive status: WISC-IV

    WISC-IV

    Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Measured: 11 years

  53. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Measured: 11 years

  54. Neurocognitive status:TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Measured: 11 years

  55. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Measured: 11 years

  56. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Measured: 11 years

  57. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Measured: 11 years

  58. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Measured: 11 years

  59. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: 11 years

  60. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Measured: 11 years

  61. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Measured: 11 years

  62. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: 11 years

  63. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Measured: 11 years

  64. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Measured: 11 years

  65. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Measured: 16 years

  66. Neurocognitive status: Movement ABC

    Neurocognitive test panel depending on age at inclusion:

    ABC Movement if inclusion between 2.5-16 years

    Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Measured: 16 years

  67. Neurocognitive status: WISC-IV

    WISC-IV Wechsler Adult Intelligence Scale, 40-160, highest is best

    Measured: 16 years

  68. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Measured: 16 years

  69. Neurocognitive status: TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Measured: 16 years

  70. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Measured: 16 years

  71. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Measured: 16 years

  72. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Measured: 16 years

  73. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Measured: 16 years

  74. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Measured: 16 years

  75. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Measured: 16 years

  76. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Measured: 16 years

  77. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Measured: 16 years

  78. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Measured: 16 years

  79. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Measured: 16 years

Secondary outcomes (360)

  1. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: Inclusion

  2. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: Inclusion

  3. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: Inclusion

  4. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: Inclusion

  5. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: Inclusion

  6. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurement on feces

    Measured: Inclusion

  7. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurement on urine

    Measured: Inclusion

  8. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurement on saliva

    Measured: Inclusion

  9. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: Inclusion

  10. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: Inclusion

  11. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: Inclusion

  12. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: Inclusion

  13. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: Inclusion

  14. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: Inclusion

  15. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: 1 year

  16. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: 1 year

  17. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: 1 year

  18. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: 1 year

  19. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: 1 year

  20. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Measured: 1 year

  21. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Measured: 1 year

  22. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Measured: 1 year

  23. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: 1 year

  24. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: 1 year

  25. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: 1 year

  26. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: 1 year

  27. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: 1 year

  28. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: 1 year

  29. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: 2 years

  30. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: 2 years

  31. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: 2 years

  32. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: 2 years

  33. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: 2 years

  34. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: 2 years

  35. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: 2 years

  36. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: 2 years

  37. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: 2 years

  38. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: 2 years

  39. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: 2 years

  40. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Measured: 2 years

  41. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Measured: 2 years

  42. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Measured: 2 years

  43. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: 6 years

  44. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: 6 years

  45. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Measured: 6 years

  46. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: 6 years

  47. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: 6 years

  48. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: 6 years

  49. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Measured: 6 years

  50. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: 6 years

  51. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: 6 years

  52. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: 6 years

  53. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Measured: 6 years

  54. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: 6 years

  55. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: 6 years

  56. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: 6 years

  57. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: 11 years

  58. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: 11 years

  59. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Measured: 11 years

  60. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: 11 years

  61. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: 11 years

  62. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: 11 years

  63. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Measured: 11 years

  64. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: 11 years

  65. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: 11 years

  66. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: 11 years

  67. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Measured: 11 years

  68. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: 11 years

  69. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: 11 years

  70. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: 11 years

  71. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Measured: 16 years

  72. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Measured: 16 years

  73. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Measured: 16 years

  74. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Measured: 16 years

  75. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Measured: 16 years

  76. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Measured: 16 years

  77. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Measured: 16 years

  78. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Measured: 16 years

  79. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Measured: 16 years

  80. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Measured: 16 years

  81. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Measured: 16 years

  82. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Measured: 16 years

  83. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Measured: 16 years

  84. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Measured: 16 years

  85. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: Inclusion

  86. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: Inclusion

  87. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: Inclusion

  88. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: 1 year

  89. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: 1 year

  90. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: 1 year

  91. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: 2 years

  92. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: 2 years

  93. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: 2 years

  94. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: 6 years

  95. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: 6 years

  96. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: 6 years

  97. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: 11 years

  98. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: 11 years

  99. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: 11 years

  100. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Measured: 16 years

  101. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Measured: 16 years

  102. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Measured: 16 years

  103. Level of Physical activity

    Accelerometer measurements

    Measured: Inclusion

  104. Level of Physical activity

    Accelerometer measurements

    Measured: 1 year

  105. Level of Physical activity

    Accelerometer measurements

    Measured: 2 years

  106. Level of Physical activity

    Accelerometer measurements

    Measured: 6 years

  107. Level of Physical activity

    Accelerometer measurements

    Measured: 11 years

  108. Level of Physical activity

    Accelerometer measurements

    Measured: 16 years

  109. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: Inclusion

  110. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: Inclusion

  111. FGF-19; Fibroblast growth factor 19

    Liver fibrosis status

    Measured: Inclusion

  112. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: Inclusion

  113. INR: international normalized ratio

    Standard liver evaluation

    Measured: Inclusion

  114. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: Inclusion

  115. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: Inclusion

  116. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: Inclusion

  117. Bilirubin

    Standard liver evaluation

    Measured: Inclusion

  118. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: Inclusion

  119. Alkaline phosphatase

    Standard liver evaluation

    Measured: Inclusion

  120. Ammonia

    Standard liver evaluation

    Measured: Inclusion

  121. Thrombocytes

    Standard liver evaluation

    Measured: Inclusion

  122. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: 1 year

  123. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Measured: 1 year

  124. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: 1 year

  125. INR: international normalized ratio

    Standard liver evaluation

    Measured: 1 year

  126. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: 1 year

  127. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: 1 year

  128. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: 1 year

  129. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: 1 year

  130. Bilirubin

    Standard liver evaluation

    Measured: 1 year

  131. Alkaline phosphatase

    Standard liver evaluation

    Measured: 1 year

  132. Ammonia

    Standard liver evaluation

    Measured: 1 year

  133. Thrombocytes

    Standard liver evaluation

    Measured: 1 year

  134. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: 1 year

  135. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: 2 years

  136. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Measured: 2 years

  137. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: 2 years

  138. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: 2 years

  139. INR: international normalized ratio

    Standard liver evaluation

    Measured: 2 years

  140. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: 2 years

  141. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: 2 years

  142. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: 2 years

  143. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: 2 years

  144. Alkaline phosphatase

    Standard liver evaluation

    Measured: 2 years

  145. Bilirubin

    Standard liver evaluation

    Measured: 2 years

  146. Ammonia

    Standard liver evaluation

    Measured: 2 years

  147. Thrombocytes

    Standard liver evaluation

    Measured: 2 years

  148. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: 6 years

  149. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: 6 years

  150. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: 6 years

  151. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Measured: 6 years

  152. INR: international normalized ratio

    Standard liver evaluation

    Measured: 6 years

  153. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: 6 years

  154. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: 6 years

  155. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: 6 years

  156. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: 6 years

  157. Bilirubin

    Standard liver evaluation

    Measured: 6 years

  158. Alkaline phosphatase

    Standard liver evaluation

    Measured: 6 years

  159. Ammonia

    Standard liver evaluation

    Measured: 6 years

  160. Thrombocytes

    Standard liver evaluation

    Measured: 6 years

  161. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: 11 years

  162. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: 11 years

  163. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Measured: 11 years

  164. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: 11 years

  165. INR: international normalized ratio

    Standard liver evaluation

    Measured: 11 years

  166. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: 11 years

  167. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: 11 years

  168. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: 11 years

  169. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: 11 years

  170. Bilirubin

    Standard liver evaluation

    Measured: 11 years

  171. Alkaline phosphatase

    Standard liver evaluation

    Measured: 11 years

  172. Ammonia

    Standard liver evaluation

    Measured: 11 years

  173. Thrombocytes

    Standard liver evaluation

    Measured: 11 years

  174. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Measured: 16 years

  175. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Measured: 16 years

  176. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Measured: 16 years

  177. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Measured: 16 years

  178. INR: international normalized ratio

    Standard liver evaluation

    Measured: 16 years

  179. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Measured: 16 years

  180. ALAT: alanine transaminase

    Standard liver evaluation

    Measured: 16 years

  181. ASAT: Aspartate transaminase

    Standard liver evaluation

    Measured: 16 years

  182. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Measured: 16 years

  183. Bilirubin

    Standard liver evaluation

    Measured: 16 years

  184. Alkaline phosphatase

    Standard liver evaluation

    Measured: 16 years

  185. Ammonia

    Standard liver evaluation

    Measured: 16 years

  186. Thrombocytes

    Standard liver evaluation

    Measured: 16 years

  187. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: Inclusion

  188. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: 1 year

  189. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: 2 years

  190. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: 6 years

  191. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: 11 years

  192. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Measured: 16 years

  193. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: Inclusion

  194. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: 1 year

  195. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: 2 years

  196. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: 6 years

  197. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: 11 years

  198. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Measured: 16 years

  199. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: Inclusion

  200. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: 1 year

  201. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: 2 years

  202. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: 6 years

  203. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: 11 years

  204. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Measured: 16 years

  205. Anthropometry: Length

    cm

    Measured: Inclusion

  206. Anthropometry: Length

    cm

    Measured: 1 year

  207. Anthropometry: Length

    cm

    Measured: 2 years

  208. Anthropometry: Height

    cm

    Measured: 6 years

  209. Anthropometry: Height

    cm

    Measured: 11 years

  210. Anthropometry: Height

    cm

    Measured: 16 years

  211. Anthropometry: Weight

    kg

    Measured: Inclusion

  212. Anthropometry: Weight

    kg

    Measured: 1 year

  213. Anthropometry: Weight

    kg

    Measured: 2 years

  214. Anthropometry: Weight

    kg

    Measured: 6 years

  215. Anthropometry: Weight

    kg

    Measured: 11 years

  216. Anthropometry: Weight

    kg

    Measured: 16 years

  217. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: Inclusion

  218. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: 1 year

  219. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: 2 years

  220. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: 6 years

  221. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: 11 years

  222. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Measured: 16 years

  223. Anthropometry: Head circumference

    cm

    Measured: Inclusion

  224. Anthropometry: Head circumference

    cm

    Measured: 1 year

  225. Anthropometry: Head circumference

    cm

    Measured: 2 years

  226. Anthropometry: Head circumference

    cm

    Measured: 6 years

  227. Anthropometry: Head circumference

    cm

    Measured: 11 years

  228. Anthropometry: Head circumference

    cm

    Measured: 16 years

  229. Essential fatty acids

    Measured: Inclusion

  230. Essential fatty acids

    Measured: 1 year

  231. Essential fatty acids

    Measured: 2 years

  232. Essential fatty acids

    Measured: 6 years

  233. Essential fatty acids

    Measured: 11 years

  234. Essential fatty acids

    Measured: 16 years

  235. IGF-1

    Insulin-like growth factor 1

    Measured: Inclusion

  236. IGF-1

    Insulin-like growth factor 1

    Measured: 1 year

  237. IGF-1

    Insulin-like growth factor 1

    Measured: 2 years

  238. IGF-1

    Insulin-like growth factor 1

    Measured: 6 years

  239. IGF-1

    Insulin-like growth factor 1

    Measured: 11 years

  240. IGF-1

    Insulin-like growth factor 1

    Measured: 16 years

  241. Meal stimulation measuring incretin

    Measured: Inclusion

  242. Meal stimulation measuring incretin

    Measured: 1 year

  243. Meal stimulation measuring incretin

    Measured: 2 years

  244. Meal stimulation measuring incretin

    Measured: 6 years

  245. Meal stimulation measuring incretin

    Measured: 11 years

  246. Meal stimulation measuring incretin

    Measured: 16 years

  247. Bile acid

    Measured: Inclusion

  248. Bile acid

    Measured: 1 year

  249. Bile acid

    Measured: 2 years

  250. Bile acid

    Measured: 6 years

  251. Bile acid

    Measured: 11 years

  252. Bile acid

    Measured: 16 years

  253. Autotaxin

    Measured: Inclusion

  254. Autotaxin

    Measured: 1 year

  255. Autotaxin

    Measured: 2 years

  256. Autotaxin

    Measured: 6 years

  257. Autotaxin

    Measured: 11 years

  258. Autotaxin

    Measured: 16 years

  259. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: Inclusion

  260. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: 1 year

  261. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: 2 years

  262. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: 6 years

  263. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: 11 years

  264. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Measured: 16 years

  265. Vaccination status

    Level of antibodies

    Measured: Inclusion

  266. Vaccination status

    Level of antibodies

    Measured: 1 year

  267. Vaccination status

    Level of antibodies

    Measured: 2 years

  268. Vaccination status

    Level of antibodies

    Measured: 6 years

  269. Vaccination status

    Level of antibodies

    Measured: 11 years

  270. Vaccination status

    Level of antibodies

    Measured: 16 years

  271. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: Inclusion

  272. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: 1 year

  273. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: 2 years

  274. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: 6 years

  275. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: 11 years

  276. Immunoresponse: RTE

    Recent thymic emigrants

    Measured: 16 years

  277. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: Inclusion

  278. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: 1 year

  279. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: 2 years

  280. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: 6 years

  281. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: 11 years

  282. Immunoresponse: Flow panel

    T-cell differentiation

    Measured: 16 years

  283. Immunoresponse: Immunoglobulin

    Measured: Inclusion

  284. Immunoresponse: Immunoglobulin

    Measured: 1 year

  285. Immunoresponse: Immunoglobulin

    Measured: 2 years

  286. Immunoresponse: Immunoglobulin

    Measured: 6 years

  287. Immunoresponse: Immunoglobulin

    Measured: 11 years

  288. Immunoresponse: Immunoglobulin

    Measured: 16 years

  289. Immunoresponse: Somatic hyper mutation

    Measured: Inclusion

  290. Immunoresponse: Somatic hyper mutation

    Measured: 1 year

  291. Immunoresponse: Somatic hyper mutation

    Measured: 2 years

  292. Immunoresponse: Somatic hyper mutation

    Measured: 6 years

  293. Immunoresponse: Somatic hyper mutation

    Measured: 11 years

  294. Immunoresponse: Somatic hyper mutation

    Measured: 16 years

  295. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: Inclusion

  296. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: 1 year

  297. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: 2 years

  298. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: 6 years

  299. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: 11 years

  300. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Measured: 16 years

  301. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: Inclusion

  302. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: 1 year

  303. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: 2 years

  304. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: 6 years

  305. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: 11 years

  306. Cytomegalovirus (CMV)

    level of CMV DNA present

    Measured: 16 years

  307. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: Inclusion

  308. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: 1 year

  309. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: 2 years

  310. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: 6 years

  311. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: 11 years

  312. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Measured: 16 years

  313. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: Inclusion

  314. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: 1 year

  315. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: 2 years

  316. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: 6 years

  317. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: 11 years

  318. MRI of liver and bile ducts with elastography

    Liver stiffness

    Measured: 16 years

  319. Fibroscan

    Liver stiffness (number)

    Measured: Inclusion

  320. Fibroscan

    Liver stiffness (number)

    Measured: 1 year

  321. Fibroscan

    Liver stiffness (number)

    Measured: 2 years

  322. Fibroscan

    Liver stiffness (number)

    Measured: 6 years

  323. Fibroscan

    Liver stiffness (number)

    Measured: 11 years

  324. Fibroscan

    Liver stiffness (number)

    Measured: 16 years

  325. Indocyanine green clearance

    Measured: Inclusion

  326. Indocyanine green clearance

    Measured: 1 year

  327. Indocyanine green clearance

    Measured: 2 years

  328. Indocyanine green clearance

    Measured: 6 years

  329. Indocyanine green clearance

    Measured: 11 years

  330. Indocyanine green clearance

    Measured: 16 years

  331. Fecal fat measurements

    Measured: Inclusion

  332. Fecal fat measurements

    Measured: 1 year

  333. Fecal fat measurements

    Measured: 2 years

  334. Fecal fat measurements

    Measured: 6 years

  335. Fecal fat measurements

    Measured: 11 years

  336. Fecal fat measurements

    Measured: 16 years

  337. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: Inclusion

  338. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: 1 year

  339. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: 2 years

  340. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: 6 years

  341. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: 11 years

  342. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Measured: 16 years

  343. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: Inclusion

  344. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: 1 year

  345. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: 2 years

  346. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: 6 years

  347. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: 11 years

  348. DEXA scan

    Dual energy x-ray absorptiometry

    Measured: 16 years

  349. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: Inclusion

  350. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: 1 year

  351. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: 2 years

  352. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: 6 years

  353. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: 11 years

  354. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Measured: 16 years

  355. Leptin

    Measured: Inclusion

  356. Leptin

    Measured: 1 year

  357. Leptin

    Measured: 2 years

  358. Leptin

    Measured: 6 years

  359. Leptin

    Measured: 11 years

  360. Leptin

    Measured: 16 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start1 Mar 2020
  3. Primary completion31 Dec 2039 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399745
Sponsor's protocol ID
H-19042934
Acronym
BILACO
Status last verified
May 2022
First submitted
8 Mar 2022
Last updated
1 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No allowed from Danish government

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Atresia and Cognitive Impairment, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vibeke Brix Christensen, MD, PhD, DMSc (+4535458842, vibeke.brix.christensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI of the brain (time frame: Inclusion). The study lists 79 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05399745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in