Celiac DiseaseNCT05186038
Mass Screening for the Early Detection of Patients With Celiac Disease.
An observational study of Celiac Disease, run by Biomedal S.L. at 2 sites in Spain.
Trial summary
The use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and immunoglobulin A (IgA) anti tissue transglutaminase (anti-tTG) antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- iVYCHECK GIP Urine and CeliacDetect
- How many people
- 1,000 participants
- Where
- 2 sitesSpain
- Study dates
- 18 Dec 2021to 31 Dec 2022
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Population comprised of patients between 2 and 18 years old who are diagnosed with celiac disease or suspected to suffer the disease. They should have willingness to perform the study and ability to collect urine samples. Moreover, the patients or their legal guardians have to sign the informed consent.
Who may be able to join
- Children and adolescents volunteers (2-18 years old).
- Regular gluten consumption.
- Willingness to perform the study and ability to collect urine samples.
- The signing of the informed consent by the volunteer and his/her legal guardians.
Who cannot join
- Related diseases or psychiatric alterations which do not recommend being included in the study as the researcher's consideration.
- Lack of foreseeable collaboration.
- Patients which do not provide samples or surveys in 70% of cases.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Scrutiny Based in a Novel Test to Help the Early Detection of Celiac Disease.
The use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and immunoglobulin A (IgA) anti tissue transglutaminase (anti-tTG) antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
This observational, cross-sectional study with no interventions applied in subjects consists on a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
The main outcome is to determine the prevalence of CD through mass screening within the pediatric and adolescent population in order to provide an early diagnosis and avoid long-term consequences which are suffered by untreated patients. As an international innovation, misdiagnosis (false negatives) because of an insufficient gluten intake are expected to be detected, thus the use of GIP detection in urine will confirm gluten ingestion at the diagnosis. Volunteers with a confirmed diagnosis of CD could be monitored by their doctors to corroborate whether a gluten-free diet improves their quality of life.
Read the detailed description
Hypothesis: the use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and IgA anti-tTG antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
Objectives:
Primary objective: to perform a mass screening in the pediatric and adolescent population (2 - 18 years old) in order to assess the prevalence of the CD providing early diagnosis of possible patients through 1 - Detection of IgA anti-tTG antibodies present in blood (to be measured by home rapid tests); 2 - Detection of GIP in urine (to be measured in situ or at a central laboratory).
Specific objectives: 1- To determine the prevalence of CD, particularly in children between 2 and 18 years old; 2 - To detect possible hidden CD cases, avoiding future irreversible damages by a late detection of this pathology such as growth impairment, decalcification, neurotoxicity or risks of suffering other autoimmune diseases; 3 - To detect misdiagnosis (false negatives) because of an insufficient gluten intake, as an international innovation.
Study design: this observational, cross-sectional study with no interventions applied in subjects consists of a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire, a short clinical questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
Study participants: volunteers from the pediatric and adolescent population between 2 and 18 years old. Gluten consumption previous to testing is an innovative requirement in order to validate the IgA anti-tTG antibodies rapid test.
Study procedure:
- Patient enrollment.
- Testing day: all participants will 1 - return the informed consent signed by them or their parents/legal guardians; 2 - complete the Celiac Symptoms Index (CSI) questionnaire and the clinical questionnaire to check if they have had any previous symptoms or other relevant information to be considered; 3 - collect urine samples in order to determine GIP presence through a immunochromatographic test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) in situ or at the central laboratory, therefore samples will need to be stored. It may be confirmed whether the volunteer was ingesting gluten when the test was performed. - A. If the result is positive, a serological test will be performed at a certified laboratory in order to confirm the volunteer's disease and a specialist to perform the diagnosis will be recommended. Whether the diagnostic is confirmed, five GlutenDetect's units will be given to each diagnosed volunteer to make sure they can check whether the diet is properly followed. - B. If the result is negative, the possibilities of suffering CD are low so any additional test will be performed. Exceptionally, those whose gluten level in urine is undetectable, but their CeliacDetect result appears as negative, a deeper study will be performed about gluten ingestion the day before through 24 hours recall.
Number of participants: a minimum of 1000 volunteers would be needed to achieve a conclusive study in order to determine at least 10 cases of CD. The calculation was made according to CD's prevalence of 1% described by several studies.
Measurements: 1- Laboratory rapid test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) for GIP determination in urine samples and immunochromatographic rapid test (CeliacDetect, Biomedal S.L., Spain) for IgA anti-tTG antibodies detection in blood; 2- CD related symptoms (CSI questionnaire). Urine samples will be analysed in situ or stored and analyzed later at a central laboratory (Biomedal S.L., Seville, Spain).
Statistical analysis: the data obtained in the study will be collected in a data base created with this purpose. Variables are tabulated through the IBM SPSS Statistics V25.0 program from International Business Machines (IBM) (Armonk, New York, USA). Different study variables will be considered: 1 - related to patients (age, gender, parent's study level); 2 - related to the "Celiac symptoms index" questionnaire (presence or not of previous symptomatology); 3 - related to samples (GIP presence in urine and IgA anti-tTG antibodies presence in blood). Each test's result will be considered as significant if the value p<0,05 and very significant if p<0,01. A confidence of 95% will be taken for intervals. When p>0,05, the result will be considered as non-significant.
- Conditions
- Celiac Disease
- Being tested
- iVYCHECK GIP Urine, CeliacDetect
- Keywords
- Mass screening, Diagnosis, Celiac disease, Urine samples, Blood samples
- Medical subject headings
- Celiac Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVYCHECK GIP UrineDiagnostic test
To determine the presence of Gluten Immunogenic Peptides (GIP) in urine samples using the immunochromatographic test iVYCHECK GIP Urine (Biomedal S.L).
CeliacDetectDiagnostic test
To determine the presence of IgA anti-tTG antibodies in blood samples using the immunochromatographic test CeliacDetect (Biomedal S.L).
| Study group | Role | What they receive |
|---|---|---|
| Population of children and adolescents between 2 and 18 years old | Population of children and adolescents between 2 and 18 years old who are diagnosed with celiac disease or are suspected to suffer the disease. Receives: Diagnostic Test: iVYCHECK GIP Urine; Diagnostic Test: CeliacDetect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Gluten Immunogenic Peptide (GIP) in urine
The immunochromatographic test iVYCHECK GIP Urine allows the detection of GIP resulting from gastrointestinal degradation of ingested gluten in urine. The detection step is based on the reaction of the 33-mer-like immunogenic peptides of gluten present in the sample with the coloured conjugated (monoclonal anti-gliadin 33-mer antibody/red-coloured microsphere) previously loaded in the cassette. Complexes spread through the cassette by capillarity and interact with a second anti-gliadin 33-mer antibody immobilized on the membrane at the test zone. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
Measured: Only the testing day.
Presence of IgA anti-tTG in blood
The immunochromatographic test CeliacDetect allows the detection of IgA anti-tTG in blood samples. The detection step is based on the union of the IgA anti-tTG with anti human IgA antibodies labeled with colloidal gold and tTG (whose origin is the erythrocyte lysis in the dilution buffer). The complex would be bounded to the stable protein line (test line) by tTG. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
Measured: Only the testing day.
Secondary outcomes (1)
Presence of previous symptoms
Number of participants with CD symptoms previously to the study as assessed by Celiac Symptoms Index (CSI) questionnaire. The scores on the CSI are recoded into a scale from 16 to 80. A score of ≥38 is considered as symptomatic.
Measured: Only the testing day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start18 Dec 2021
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedal S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville, FUNDACION IHP
- Responsible party
- Sponsor
- Investigators
- Ignacio Salamanca, Study chair, FUNDACION IHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186038
- Sponsor's protocol ID
- CELISIN
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Husby S, Koletzko S, Korponay-Szabo IR, Mearin ML, Phillips A, Shamir R, Troncone R, Giersiepen K, Branski D, Catassi C, Lelgeman M, Maki M, Ribes-Koninckx C, Ventura A, Zimmer KP; ESPGHAN Working Group on Coeliac Disease Diagnosis; ESPGHAN Gastroenterology Committee; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition guidelines for the diagnosis of coeliac disease. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):136-60. doi: 10.1097/MPG.0b013e31821a23d0.
PubMed 22197856Bardella MT, Velio P, Cesana BM, Prampolini L, Casella G, Di Bella C, Lanzini A, Gambarotti M, Bassotti G, Villanacci V. Coeliac disease: a histological follow-up study. Histopathology. 2007 Mar;50(4):465-71. doi: 10.1111/j.1365-2559.2007.02621.x.
PubMed 17448022Holmes GK, Prior P, Lane MR, Pope D, Allan RN. Malignancy in coeliac disease--effect of a gluten free diet. Gut. 1989 Mar;30(3):333-8. doi: 10.1136/gut.30.3.333.
PubMed 2707633Kaukinen K, Peraaho M, Lindfors K, Partanen J, Woolley N, Pikkarainen P, Karvonen AL, Laasanen T, Sievanen H, Maki M, Collin P. Persistent small bowel mucosal villous atrophy without symptoms in coeliac disease. Aliment Pharmacol Ther. 2007 May 15;25(10):1237-45. doi: 10.1111/j.1365-2036.2007.03311.x.
PubMed 17451570Silano M, Volta U, Vincenzi AD, Dessi M, Vincenzi MD; Collaborating Centers of the Italian Registry of the Complications of Coeliac Disease. Effect of a gluten-free diet on the risk of enteropathy-associated T-cell lymphoma in celiac disease. Dig Dis Sci. 2008 Apr;53(4):972-6. doi: 10.1007/s10620-007-9952-8. Epub 2007 Oct 13.
PubMed 17934841Cosnes J, Cellier C, Viola S, Colombel JF, Michaud L, Sarles J, Hugot JP, Ginies JL, Dabadie A, Mouterde O, Allez M, Nion-Larmurier I; Groupe D'Etude et de Recherche Sur la Maladie Coeliaque. Incidence of autoimmune diseases in celiac disease: protective effect of the gluten-free diet. Clin Gastroenterol Hepatol. 2008 Jul;6(7):753-8. doi: 10.1016/j.cgh.2007.12.022. Epub 2008 Feb 6.
PubMed 18255352Castano L, Blarduni E, Ortiz L, Nunez J, Bilbao JR, Rica I, Martul P, Vitoria JC. Prospective population screening for celiac disease: high prevalence in the first 3 years of life. J Pediatr Gastroenterol Nutr. 2004 Jul;39(1):80-4. doi: 10.1097/00005176-200407000-00016.
PubMed 15187786Tanpowpong P, Broder-Fingert S, Katz AJ, Camargo CA Jr. Age-related patterns in clinical presentations and gluten-related issues among children and adolescents with celiac disease. Clin Transl Gastroenterol. 2012 Feb 16;3(2):e9. doi: 10.1038/ctg.2012.4.
PubMed 23238134Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
PubMed 23609613Dorn SD, Matchar DB. Cost-effectiveness analysis of strategies for diagnosing celiac disease. Dig Dis Sci. 2008 Mar;53(3):680-8. doi: 10.1007/s10620-007-9939-5. Epub 2007 Oct 13.
PubMed 17934849Collin P. Should adults be screened for celiac disease? What are the benefits and harms of screening? Gastroenterology. 2005 Apr;128(4 Suppl 1):S104-8. doi: 10.1053/j.gastro.2005.02.021.
PubMed 15825117Lagerqvist C, Dahlbom I, Hansson T, Jidell E, Juto P, Olcen P, Stenlund H, Hernell O, Ivarsson A. Antigliadin immunoglobulin A best in finding celiac disease in children younger than 18 months of age. J Pediatr Gastroenterol Nutr. 2008 Oct;47(4):428-35. doi: 10.1097/MPG.0b013e31817d80f4.
PubMed 18852634Korponay-Szabo IR, Dahlbom I, Laurila K, Koskinen S, Woolley N, Partanen J, Kovacs JB, Maki M, Hansson T. Elevation of IgG antibodies against tissue transglutaminase as a diagnostic tool for coeliac disease in selective IgA deficiency. Gut. 2003 Nov;52(11):1567-71. doi: 10.1136/gut.52.11.1567.
PubMed 14570724
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scrutiny Based in a Novel Test to Help the Early Detection of Celiac Disease.
- ClinicalTrials.gov ID
- NCT05186038
- Acronym / sponsor ID
- CELISIN
- Conditions
- Celiac Disease
- Keywords
- Mass screening, Diagnosis, Celiac disease, Urine samples, Blood samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Biomedal S.L.University, hospital or other
- Collaborators
- University of Seville, FUNDACION IHP
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and immunoglobulin A (IgA) anti tissue transglutaminase (anti-tTG) antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
This observational, cross-sectional study with no interventions applied in subjects consists on a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
The main outcome is to determine the prevalence of CD through mass screening within the pediatric and adolescent population in order to provide an early diagnosis and avoid long-term consequences which are suffered by untreated patients. As an international innovation, misdiagnosis (false negatives) because of an insufficient gluten intake are expected to be detected, thus the use of GIP detection in urine will confirm gluten ingestion at the diagnosis. Volunteers with a confirmed diagnosis of CD could be monitored by their doctors to corroborate whether a gluten-free diet improves their quality of life.
Detailed description
Hypothesis: the use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and IgA anti-tTG antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
Objectives:
Primary objective: to perform a mass screening in the pediatric and adolescent population (2 - 18 years old) in order to assess the prevalence of the CD providing early diagnosis of possible patients through 1 - Detection of IgA anti-tTG antibodies present in blood (to be measured by home rapid tests); 2 - Detection of GIP in urine (to be measured in situ or at a central laboratory).
Specific objectives: 1- To determine the prevalence of CD, particularly in children between 2 and 18 years old; 2 - To detect possible hidden CD cases, avoiding future irreversible damages by a late detection of this pathology such as growth impairment, decalcification, neurotoxicity or risks of suffering other autoimmune diseases; 3 - To detect misdiagnosis (false negatives) because of an insufficient gluten intake, as an international innovation.
Study design: this observational, cross-sectional study with no interventions applied in subjects consists of a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire, a short clinical questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
Study participants: volunteers from the pediatric and adolescent population between 2 and 18 years old. Gluten consumption previous to testing is an innovative requirement in order to validate the IgA anti-tTG antibodies rapid test.
Study procedure:
- Patient enrollment.
- Testing day: all participants will 1 - return the informed consent signed by them or their parents/legal guardians; 2 - complete the Celiac Symptoms Index (CSI) questionnaire and the clinical questionnaire to check if they have had any previous symptoms or other relevant information to be considered; 3 - collect urine samples in order to determine GIP presence through a immunochromatographic test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) in situ or at the central laboratory, therefore samples will need to be stored. It may be confirmed whether the volunteer was ingesting gluten when the test was performed. - A. If the result is positive, a serological test will be performed at a certified laboratory in order to confirm the volunteer's disease and a specialist to perform the diagnosis will be recommended. Whether the diagnostic is confirmed, five GlutenDetect's units will be given to each diagnosed volunteer to make sure they can check whether the diet is properly followed. - B. If the result is negative, the possibilities of suffering CD are low so any additional test will be performed. Exceptionally, those whose gluten level in urine is undetectable, but their CeliacDetect result appears as negative, a deeper study will be performed about gluten ingestion the day before through 24 hours recall.
Number of participants: a minimum of 1000 volunteers would be needed to achieve a conclusive study in order to determine at least 10 cases of CD. The calculation was made according to CD's prevalence of 1% described by several studies.
Measurements: 1- Laboratory rapid test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) for GIP determination in urine samples and immunochromatographic rapid test (CeliacDetect, Biomedal S.L., Spain) for IgA anti-tTG antibodies detection in blood; 2- CD related symptoms (CSI questionnaire). Urine samples will be analysed in situ or stored and analyzed later at a central laboratory (Biomedal S.L., Seville, Spain).
Statistical analysis: the data obtained in the study will be collected in a data base created with this purpose. Variables are tabulated through the IBM SPSS Statistics V25.0 program from International Business Machines (IBM) (Armonk, New York, USA). Different study variables will be considered: 1 - related to patients (age, gender, parent's study level); 2 - related to the "Celiac symptoms index" questionnaire (presence or not of previous symptomatology); 3 - related to samples (GIP presence in urine and IgA anti-tTG antibodies presence in blood). Each test's result will be considered as significant if the value p<0,05 and very significant if p<0,01. A confidence of 95% will be taken for intervals. When p>0,05, the result will be considered as non-significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of children and adolescents between 2 and 18 years old | – | Diagnostic Test: iVYCHECK GIP Urine, Diagnostic Test: CeliacDetectPopulation of children and adolescents between 2 and 18 years old who are diagnosed with celiac disease or are suspected to suffer the disease. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population comprised of patients between 2 and 18 years old who are diagnosed with celiac disease or suspected to suffer the disease. They should have willingness to perform the study and ability to collect urine samples. Moreover, the patients or their legal guardians have to sign the informed consent.
Key inclusion criteria (4 listed)
- Children and adolescents volunteers (2-18 years old).
- Regular gluten consumption.
- Willingness to perform the study and ability to collect urine samples.
- The signing of the informed consent by the volunteer and his/her legal guardians.
Key exclusion criteria (3 listed)
- Related diseases or psychiatric alterations which do not recommend being included in the study as the researcher's consideration.
- Lack of foreseeable collaboration.
- Patients which do not provide samples or surveys in 70% of cases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iVYCHECK GIP UrineTo determine the presence of Gluten Immunogenic Peptides (GIP) in urine samples using the immunochromatographic test iVYCHECK GIP Urine (Biomedal S.L). | Diagnostic test | Population of children and adolescents between 2 and 18 years old |
| CeliacDetectTo determine the presence of IgA anti-tTG antibodies in blood samples using the immunochromatographic test CeliacDetect (Biomedal S.L). | Diagnostic test | Population of children and adolescents between 2 and 18 years old |
Primary outcome
Presence of Gluten Immunogenic Peptide (GIP) in urine
Time frame: Only the testing day.
The immunochromatographic test iVYCHECK GIP Urine allows the detection of GIP resulting from gastrointestinal degradation of ingested gluten in urine. The detection step is based on the reaction of the 33-mer-like immunogenic peptides of gluten present in the sample with the coloured conjugated (monoclonal anti-gliadin 33-mer antibody/red-coloured microsphere) previously loaded in the cassette. Complexes spread through the cassette by capillarity and interact with a second anti-gliadin 33-mer antibody immobilized on the membrane at the test zone. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
Presence of IgA anti-tTG in blood
Time frame: Only the testing day.
The immunochromatographic test CeliacDetect allows the detection of IgA anti-tTG in blood samples. The detection step is based on the union of the IgA anti-tTG with anti human IgA antibodies labeled with colloidal gold and tTG (whose origin is the erythrocyte lysis in the dilution buffer). The complex would be bounded to the stable protein line (test line) by tTG. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
1 secondary outcome
Presence of previous symptoms
Time frame: Only the testing day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 22197856Husby S, Koletzko S, Korponay-Szabo IR, Mearin ML, Phillips A, Shamir R, Troncone R, Giersiepen K, Branski D, Catassi C, Lelgeman M, Maki M, Ribes-Koninckx C, Ventura A, Zimmer KP; ESPGHAN Working Group on Coeliac Disease Diagnosis; ESPGHAN Gastroenterology Committee; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition guidelines for the diagnosis of coeliac disease. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):136-60. doi: 10.1097/MPG.0b013e31821a23d0.
- Background: PubMed 17448022Bardella MT, Velio P, Cesana BM, Prampolini L, Casella G, Di Bella C, Lanzini A, Gambarotti M, Bassotti G, Villanacci V. Coeliac disease: a histological follow-up study. Histopathology. 2007 Mar;50(4):465-71. doi: 10.1111/j.1365-2559.2007.02621.x.
- Background: PubMed 2707633Holmes GK, Prior P, Lane MR, Pope D, Allan RN. Malignancy in coeliac disease--effect of a gluten free diet. Gut. 1989 Mar;30(3):333-8. doi: 10.1136/gut.30.3.333.
- Background: PubMed 17451570Kaukinen K, Peraaho M, Lindfors K, Partanen J, Woolley N, Pikkarainen P, Karvonen AL, Laasanen T, Sievanen H, Maki M, Collin P. Persistent small bowel mucosal villous atrophy without symptoms in coeliac disease. Aliment Pharmacol Ther. 2007 May 15;25(10):1237-45. doi: 10.1111/j.1365-2036.2007.03311.x.
- Background: PubMed 17934841Silano M, Volta U, Vincenzi AD, Dessi M, Vincenzi MD; Collaborating Centers of the Italian Registry of the Complications of Coeliac Disease. Effect of a gluten-free diet on the risk of enteropathy-associated T-cell lymphoma in celiac disease. Dig Dis Sci. 2008 Apr;53(4):972-6. doi: 10.1007/s10620-007-9952-8. Epub 2007 Oct 13.
- Background: PubMed 18255352Cosnes J, Cellier C, Viola S, Colombel JF, Michaud L, Sarles J, Hugot JP, Ginies JL, Dabadie A, Mouterde O, Allez M, Nion-Larmurier I; Groupe D'Etude et de Recherche Sur la Maladie Coeliaque. Incidence of autoimmune diseases in celiac disease: protective effect of the gluten-free diet. Clin Gastroenterol Hepatol. 2008 Jul;6(7):753-8. doi: 10.1016/j.cgh.2007.12.022. Epub 2008 Feb 6.
- Background: PubMed 15187786Castano L, Blarduni E, Ortiz L, Nunez J, Bilbao JR, Rica I, Martul P, Vitoria JC. Prospective population screening for celiac disease: high prevalence in the first 3 years of life. J Pediatr Gastroenterol Nutr. 2004 Jul;39(1):80-4. doi: 10.1097/00005176-200407000-00016.
- Background: PubMed 23238134Tanpowpong P, Broder-Fingert S, Katz AJ, Camargo CA Jr. Age-related patterns in clinical presentations and gluten-related issues among children and adolescents with celiac disease. Clin Transl Gastroenterol. 2012 Feb 16;3(2):e9. doi: 10.1038/ctg.2012.4.
- Background: PubMed 23609613Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
- Background: PubMed 17934849Dorn SD, Matchar DB. Cost-effectiveness analysis of strategies for diagnosing celiac disease. Dig Dis Sci. 2008 Mar;53(3):680-8. doi: 10.1007/s10620-007-9939-5. Epub 2007 Oct 13.
- Background: PubMed 15825117Collin P. Should adults be screened for celiac disease? What are the benefits and harms of screening? Gastroenterology. 2005 Apr;128(4 Suppl 1):S104-8. doi: 10.1053/j.gastro.2005.02.021.
- Background: PubMed 18852634Lagerqvist C, Dahlbom I, Hansson T, Jidell E, Juto P, Olcen P, Stenlund H, Hernell O, Ivarsson A. Antigliadin immunoglobulin A best in finding celiac disease in children younger than 18 months of age. J Pediatr Gastroenterol Nutr. 2008 Oct;47(4):428-35. doi: 10.1097/MPG.0b013e31817d80f4.
- Celiac Disease Early Diagnosis ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Salamanca study chair
FUNDACION IHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Biomedal S.L. at 2 sites in Spain.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Gluten Immunogenic Peptide (GIP) in urine (time frame: Only the testing day.). The study lists 2 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 NCT05186038, which also lists 13 linked publications.
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 29 Apr 2024.