Quantification of Gluten Peptides in Feces

NCT02711397 | Completed

• 1 other identifier: DELIAC
• Study Type: observational
• Target: 272
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Adherence to gluten-free diet

  two years

Study Arms (3)

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

Observational study OTHER

Comparison excretion levels of gluten immunogenic peptides

Celiac patients; Negative controls; Positive controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Biomedal S.L.: lead

Related Publications (2)

• 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.

  PMID: 31074004 DERIVED

• 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.

  PMID: 27644734 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples

MeSH Terms

Conditions

Celiac Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Carolina Sousa, PhD

  Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 17, 2016
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 29, 2024

Record last verified: 2016-03