How well do tests that measure gluten in the faeces detect low-level dietary gluten exposure in people with coeliac disease?

Not Applicable

• Conditions: Coeliac Disease; Autoimmune; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12620000259943
• Lead Sponsor: A/Professor Jason Tye-Din

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults 18 up to 70 years of age including males and females.
A diagnosis of coeliac disease based on consensus criteria (positive coeliac serology and typical small intestinal enteropathy at diagnosis), and following a strict gluten free diet for at least 12 months with negative coeliac serology and normal Celiac Dietary Adherence Test (CDAT) at baseline.
Faecal samples from coeliac or non-coeliac (healthy) participants not following a gluten free diet will also be collected and serve as positive controls for the faecal assay.

Exclusion Criteria

Inability to give informed consent, understand English, or suffering from a medical condition that the investigator believes may affect the safe conduct of the trial or complicate interpretation of results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified