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CompletedNCT02711397DELIACUpdated Apr 29, 2024

Quantification of Gluten Peptides in Feces

An observational study in Celiac Disease, sponsored by Biomedal S.L.. Completed. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Biomedal S.L. · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
272
Sex
All
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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.

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Conditions studied

  • Celiac Disease

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In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.

This study's enrollment of 272 is above the median of 159 across 125 observational studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Biomedal S.L. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Celiac patients following a GFD for at least one year prior to the inclusion in the study

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
272 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Celiac patients

    Celiac patients following a GFD for at least one year prior to the inclusion in the study.

    Other: Observational study

  • Positive controls

    Healthy children and adults on an unrestricted gluten containing diet.

    Other: Observational study

  • Negative controls

    Healthy infants who were exclusively fed with infant formula specifically labelled as gluten-free.

    Other: Observational study

Interventions

  • OtherObservational study

    Comparison excretion levels of gluten immunogenic peptides

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What researchers measure

Primary outcomes

  1. Adherence to gluten-free diet

    Time frame: two years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Comino I, Segura V, Ortigosa L, Espin B, Castillejo G, Garrote JA, Sierra C, Millan A, Ribes-Koninckx C, Roman E, Rodriguez-Herrera A, Diaz J, Silvester JA, Cebolla A, Sousa C. Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet. Aliment Pharmacol Ther. 2019 Jun;49(12):1484-1492. doi: 10.1111/apt.15277. Epub 2019 May 10. PubMed 31074004 ↗
  • Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20. Erratum In: Am J Gastroenterol. 2017 Jul;112(7):1208. doi: 10.1038/ajg.2017.110. PubMed 27644734 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02711397
Lead sponsor
Biomedal S.L.
Responsible party
Sponsor
First posted
Mar 17, 2016
Start date
Apr 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Apr 29, 2024

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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