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Chronic PancreatitisNCT04476056

Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

A study testing Intensified Nutritional Therapy in people with Chronic Pancreatitis and Malnutrition, run by University Medicine Greifswald at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pancreatitis, Malnutrition, Sarcopenia
What is being tested?
Intensified Nutritional Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
28 May 2019to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)
  • Diagnosis of malnutrition

Who cannot join

  • Pregnant or breast feeding
  • Implanted defibrillator or pacemaker
  • History of pancreatic Cancer
  • Any other malignant tumor disease within the last 3 years
  • Concomitant liver cirrhosis

Trial locations and contacts

1 site in 1 country.

Prof. Dr. med. Markus M. Lerch contact

+493834867230

markus.lerch@med.uni-greifswald.de

Germany1 site, 1 recruiting

  • University Medicine Greifswald

    Greifswald, 17475

    Prof. Dr. med. Markus M. Lerch, +493834867230, markus.lerch@med.uni-greifswald.de

    Ali A Aghdassi, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months

Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.

Read the detailed description

Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.

Being tested
Intensified Nutritional Therapy
Medical subject headings
Pancreatitis, Chronic, Malnutrition, Sarcopenia

What participants receive

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

  • Intensified Nutritional TherapyOther

    Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.

Study groups in NCT04476056
Study groupRoleWhat they receive
Chronic Pancreatitis + MalnutritionExperimentalMalnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.
Receives: Other: Intensified Nutritional Therapy

What is being measured

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

  1. Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria

    Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months

    Measured: 6 months

Secondary outcomes (72)

  1. Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria

    Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria

    Measured: 28 days, 3 months, 6 months

  2. Dropout Rate

    Dropout Rate

    Measured: 28 days, 3 months, 6 months

  3. Compliance to Oral Nutritional Supplements

    Compliance is assessed by a standardized telephone interview comparing recommended and current intake

    Measured: 28 days, 3 months, 6 months

  4. Compliance to Dietary Counselling

    Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions

    Measured: 28 days, 3 months, 6 months

  5. Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria

    Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria

    Measured: 28 days, 3 months, 6 months

  6. Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria

    Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria

    Measured: 28 days, 3 months, 6 months

  7. Reduced Body Mass Index

    Changes in prevalence of reduced body mass index (< 18,5 kg/m², < 20 kg/m² if age < 70 yrs, < 22 kg/m² if age ≥ 70 yrs)

    Measured: 28 days, 3 months, 6 months

  8. Reduced Fat Free Mass Index

    Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)

    Measured: 28 days, 3 months, 6 months

  9. Reduced Skeletal Muscle Mass Index

    Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)

    Measured: 28 days, 3 months, 6 months

  10. Reduced Gait Speed

    Changes in prevalence of reduced gait speed (< 0,8 m/s)

    Measured: 28 days, 3 months, 6 months

  11. Reduced Muscle Strength

    Changes in prevalence of reduced muscle strength (< 19,3 kg if female, < 30,3 kg if male)

    Measured: 28 days, 3 months, 6 months

  12. Body Weight

    Changes in body weight measured in kilograms

    Measured: 28 days, 3 months, 6 months

  13. Height

    Changes height measured in centimeters

    Measured: 28 days, 3 months, 6 months

  14. Body Mass Index

    Changes in body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)

    Measured: 28 days, 3 months, 6 months

  15. Waist Circumference

    Changes in waist circumference measured in centimeters

    Measured: 28 days, 3 months, 6 months

  16. Hip Circumference

    Changes in hip circumference measured in centimeters

    Measured: 28 days, 3 months, 6 months

  17. Waist-to-Hip Ratio

    Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)

    Measured: 28 days, 3 months, 6 months

  18. Triceps Skinfold Thickness

    Changes in triceps skinfold thickness measured in millimeters

    Measured: 28 days, 3 months, 6 months

  19. Upper Arm Circumference

    Changes in upper arm circumference measured in centimeters

    Measured: 28 days, 3 months, 6 months

  20. Fat Free Mass

    Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  21. Skeletal Muscle Mass

    Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  22. Fat Mass

    Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  23. Total Body Water

    Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  24. Extracellular Water

    Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  25. Phase Angle

    Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 28 days, 3 months, 6 months

  26. Energy Intake

    Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)

    Measured: 28 days, 3 months, 6 months

  27. Protein Intake

    Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)

    Measured: 28 days, 3 months, 6 months

  28. Carbohydrate Intake

    Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)

    Measured: 28 days, 3 months, 6 months

  29. Fat Intake

    Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)

    Measured: 28 days, 3 months, 6 months

  30. Dietary Fiber Intake

    Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)

    Measured: 28 days, 3 months, 6 months

  31. Physical Activity

    Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form

    Measured: 28 days, 3 months, 6 months

  32. Hemoglobin

    Changes in hemoglobin level

    Measured: 28 days, 3 months, 6 months

  33. Hematocrit

    Changes in hematocrit level

    Measured: 28 days, 3 months, 6 months

  34. Mean Corpuscular Volume

    Changes in mean corpuscular volume

    Measured: 28 days, 3 months, 6 months

  35. Mean Corpuscular Hemoglobin Concentration

    Changes in mean corpuscular hemoglobin concentration

    Measured: 28 days, 3 months, 6 months

  36. Reticulocyte Count

    Changes in reticulocyte count

    Measured: 28 days, 3 months, 6 months

  37. Sodium

    Changes in plasma concentration of sodium

    Measured: 28 days, 3 months, 6 months

  38. Potassium

    Changes in plasma concentration of potassium

    Measured: 28 days, 3 months, 6 months

  39. Calcium

    Changes in plasma concentration of calcium

    Measured: 28 days, 3 months, 6 months

  40. Magnesium

    Changes in plasma concentration of magnesium

    Measured: 28 days, 3 months, 6 months

  41. Phosphate

    Changes in plasma concentration of phosphate

    Measured: 28 days, 3 months, 6 months

  42. Aspartate Transaminase

    Changes in plasma concentration of aspartate transferase

    Measured: 28 days, 3 months, 6 months

  43. Alanine Aminotransferase

    Changes in plasma concentration of alanine aminotransferase

    Measured: 28 days, 3 months, 6 months

  44. Gamma-glutamyl Transferase

    Changes in plasma concentration of gamma-glutamyl transferase

    Measured: 28 days, 3 months, 6 months

  45. Alkaline Phosphatase

    Changes in plasma concentration of alkaline phosphatase

    Measured: 28 days, 3 months, 6 months

  46. Bilirubin

    Changes in plasma concentration of bilirubin

    Measured: 28 days, 3 months, 6 months

  47. C-reactive Protein

    Changes in plasma concentration of C-reactive protein

    Measured: 28 days, 3 months, 6 months

  48. Interleukin-1 Beta

    Changes in serum concentration of interleukin-1 beta

    Measured: 28 days, 3 months, 6 months

  49. Interleukin-6

    Changes in plasma concentration of interleukin-6

    Measured: 28 days, 3 months, 6 months

  50. Tumor Necrosis Factor Alpha

    Changes in serum concentration of tumor necrosis factor alpha

    Measured: 28 days, 3 months, 6 months

  51. Albumin

    Changes in plasma concentration of albumin

    Measured: 28 days, 3 months, 6 months

  52. Creatinine

    Changes in plasma concentration of creatinine

    Measured: 28 days, 3 months, 6 months

  53. Urea

    Changes in plasma concentration of urea

    Measured: 28 days, 3 months, 6 months

  54. Uric Acid

    Changes in plasma concentration of uric acid

    Measured: 28 days, 3 months, 6 months

  55. Glucose

    Changes in plasma concentration of glucose

    Measured: 28 days, 3 months, 6 months

  56. Glycated hemoglobin

    Changes in plasma concentration of glycated hemoglobin

    Measured: 28 days, 3 months, 6 months

  57. Insulin

    Changes in serum concentration of insulin

    Measured: 28 days, 3 months, 6 months

  58. Total Cholesterol

    Changes in plasma concentration of total cholesterol

    Measured: 28 days, 3 months, 6 months

  59. High-density Lipoprotein Cholesterol

    Changes in plasma concentration of high-density lipoprotein cholesterol

    Measured: 28 days, 3 months, 6 months

  60. Low-density Lipoprotein Cholesterol

    Changes in plasma concentration of high-density lipoprotein cholesterol

    Measured: 28 days, 3 months, 6 months

  61. Triglycerides

    Changes in plasma concentration of triglycerides

    Measured: 28 days, 3 months, 6 months

  62. Non-essential Fatty Acids

    Changes in plasma concentration of non-essential fatty acids

    Measured: 28 days, 3 months, 6 months

  63. Zinc

    Changes in serum concentration of zinc

    Measured: 28 days, 3 months, 6 months

  64. Iron

    Changes in plasma concentration of iron

    Measured: 28 days, 3 months, 6 months

  65. Hand Grip Strength

    Changes in maximal hand grip strength

    Measured: 28 days, 3 months, 6 months

  66. Gait Speed

    Changes in gait speed

    Measured: 28 days, 3 months, 6 months

  67. Anxiety and Depression

    Changes in anxiety and depression assessed by the German version of the Hospital Anxiety and Depression Scale (HADS-D). For both the anxiety and the depression subscale scores range from 0-21, with higher values indicating a worse outcome.

    Measured: 28 days, 3 months, 6 months

  68. Fatigue

    Changes in fatigue assessed by the German version of the Fatigue Severity Scale (FSS). Scores range from 1-7, with higher values indicating a better outcome.

    Measured: 28 days, 3 months, 6 months

  69. Loneliness

    Changes in loneliness assessed by the German Version of the 6-item De Jong Gierveld Loneliness Scale. Scores range from 0-6, with higher values indicating worse outcome.

    Measured: 28 days, 3 months, 6 months

  70. Intestinal Microbiome

    Changes in the intestinal microbiome

    Measured: 28 days, 3 months, 6 months

  71. Plasma Metabolome

    Changes in the plasma metabolome

    Measured: 28 days, 3 months, 6 months

  72. Plasma Transcriptome

    Changes in the plasma transcriptome

    Measured: 28 days, 3 months, 6 months

Timeline

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

  1. First posted17 Jul 2020
  2. Study start28 May 2019
  3. Primary completion30 May 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility Study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04476056
Sponsor's protocol ID
BB 069/19
Status last verified
Jul 2020
First submitted
29 Jun 2020
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wiese ML, Frost F, Meyer F, Muller J, Valentini L, Rischmuller K, Lamprecht G, Steveling A, Lerch MM, Aghdassi AA. An intensified trans-sectoral nutritional intervention in malnourished patients with chronic pancreatitis improves diseases prognosis and identifies potential biomarkers of nutritional status. Front Med (Lausanne). 2024 Oct 8;11:1446699. doi: 10.3389/fmed.2024.1446699. eCollection 2024.

    PubMed 39440042

Questions about this trial

What is this clinical trial studying?

A study testing Intensified Nutritional Therapy in people with Chronic Pancreatitis and Malnutrition, run by University Medicine Greifswald at 1 site in Germany.

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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. 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 Germany. 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?

Results are not available in the source record.

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

Contact Prof. Dr. med. Markus M. Lerch (+493834867230, markus.lerch@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria (time frame: 6 months). 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 NCT04476056, which also lists 1 linked publication.

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 17 Jul 2020.

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