Quantification of Gluten Peptides in Feces

Completed

• Conditions: Celiac Disease
• Interventions: Other: Observational study

• Registration Number: NCT02711397
• Lead Sponsor: Biomedal S.L.

Brief Summary

Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serologic tests for CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring.

We performed a prospective, non-randomized, multicentre study including 188 CD patients on a GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• The study group consisted of celiac patients following a GFD for at least one year prior to the inclusion in the study and they were required to have an HLA-DQ2 or HLA-DQ8 haplotype and an histologically abnormal duodenal biopsy (grade Marsh IIIB or IIIC) at the time of diagnosis, supported by positive serum anti-endomysium IgA antibodies and/or anti-tissue transglutaminase (anti-tTG) IgA antibodies.
• The positive and negative control groups was comprised of healthy asymptomatic subjects in whom CD had been ruled out and who were not suspected of having any other gastrointestinal condition

Exclusion Criteria

• All study patients included history of kidney or liver disease, and history of severe psychiatric disease or seizure disorder.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive controls	Observational study	Healthy children and adults on an unrestricted gluten containing diet.
Celiac patients	Observational study	Celiac patients following a GFD for at least one year prior to the inclusion in the study.
Negative controls	Observational study	Healthy infants who were exclusively fed with infant formula specifically labelled as gluten-free.

Primary Outcome Measures

Name	Time	Method
Adherence to gluten-free diet	two years