Impact of Gluten Contamination in Celiac Patients Clinically Responsive and Unresponsive to the Gluten-free Diet

NCT ID: NCT05066191

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-03-31

Brief Summary

The primary aim of the study is to detect the presence of gluten immunogenic peptides (GIP) in urine samples from celiac patients on a gluten-free diet clinically responsive and non-responsive to dietary treatment and from suspected celiac patients already on a gluten-free diet.

Detailed Description

Once a year, celiac patients perform a clinical (gastroenterological visit) and blood chemistry (blood tests) check. At the Center for the Prevention and Diagnosis of Celiac Disease, about 1400 check-ups of celiac patients are carried out per year. During this annual control visit, consecutive patients afferent to the center and suffering from celiac disease who have been treated for more than 6 months, clinically "responsive" and "non-responsive" to the gluten free diet (GFD), will be invited to participate in the proposed study. Those who participate will be given the symptom questionnaires (VAS), the food questionnaire in order to evaluate the relevance of the symptoms reported and the type of diet followed by the patient and the adherence test to the gluten-free diet (CDAT). Urine samples will be collected to test the presence of GIP (gluten immunogenic peptides) and for patients whose samples test positive, will be asked for a stool sample to detect GIP.

Subjects with suspected celiac disease but already on a gluten-free diet will undergo a challenge, or the reintroduction of gluten in incremental steps of three weeks (routinely performed as per the instructions of the Italian Health Care System).

Conditions

Celiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age: 18 to 65 years old
• Gender: Males and Females
• Patients: suffering from Celiac Disease and suspected, but already on a gluten-free diet

Exclusion Criteria

• Celiac patients less than 6 months after diagnosis
• Celiac patients reporting intentional gluten ingestion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Luca Elli, MD, PhD

Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Elli, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Locations

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maurizio Vecchi, MD

Role: CONTACT

maurizio.vecchi@policlinico.mi.it

0255033418

References

Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.

Reference Type: RESULT

PMID: 22258271 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27644734 (View on PubMed)

Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25.

Reference Type: RESULT

PMID: 26608460 (View on PubMed)

Other Identifiers

169_2021

Identifier Type: -

Identifier Source: org_study_id