NCT02711397

Quantification of Gluten Peptides in Feces

Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-free Diet

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 272 (actual)
• Sponsor: Biomedal S.L. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
OTHER	Observational study	Comparison excretion levels of gluten immunogenic peptides

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2016-03-17
• Last updated: 2024-04-29