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Quantification of Gluten Peptides in Feces

NCT02711397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2024-04-29

No results posted yet for this study

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

Interventions

OTHER

Observational study

Comparison excretion levels of gluten immunogenic peptides

Sponsors & Collaborators

  • Biomedal S.L.

    lead OTHER

Principal Investigators

  • Carolina Sousa, PhD · Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711397 on ClinicalTrials.gov