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

Impact of Gluten Contamination in Celiac Patients Clinically

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05066191
Acronym
GIP
Enrollment
300
Registered
2021-10-04
Start date
2019-02-01
Completion date
2022-03-31
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

non celiac gluten sensitivity, gluten reintroduction, GIP

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).

Interventions

None listed

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
GIP3 weeksGIP Immunogenic Peptide Assay in Urine

Secondary

MeasureTime frameDescription
Gluten-free diet3 weeksAssessment of adherence to gluten-free diet and of gluten food intake

Countries

Italy

Contacts

Primary ContactMaurizio Vecchi, MD
maurizio.vecchi@policlinico.mi.it0255033418

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026