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

Celiac Disease Clinical Trial

— GIP  

Official title:

Impact of Gluten Contamination in Celiac Patients Clinically

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066191
• Other study ID #: 169_2021
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Maurizio Vecchi, MD
• Phone: 0255033418
• Email: maurizio.vecchi[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Comino I, Fernández-Bañares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodríguez-Herrera A, Salazar JC, Caunedo Á, Marugán-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nuñez A, Vaquero L, Vegas AM, Crespo L, Fernánd — View Citation

Comino I, Real A, Vivas S, Síglez MÁ, Caminero A, Nistal E, Casqueiro J, Rodríguez-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. 20 — View Citation

Moreno ML, Cebolla Á, Muñoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro Á, León F, Rodríguez-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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GIP	GIP Immunogenic Peptide Assay in Urine	3 weeks
Secondary	Gluten-free diet	Assessment of adherence to gluten-free diet and of gluten food intake	3 weeks