None listed
Conditions
Brief summary
Achieving optimal health for people with CD requires a strict gluten free diet. Unfortunately, accidental gluten intake is common. Assessing for gluten intake based on dietitian evaluation or coeliac serology lacks sensitivity and small intestinal histology requires an invasive test. This study will assess a new test that measures gluten (gluten immunogenic peptides) in a faecal (stool) sample. Participants will consume a gluten-free cookie containing either a small amount of gluten (equivalent to a “real-world” contamination) or placebo and their faeces assessed. The study will inform how this objective test can be deployed in clinical practice to support people following a strict gluten free diet.
Interventions
A randomised, double-blind food challenge study. Adult participants with treated coeliac disease be randomised to consume a single gluten-free cookie (the intervention) containing vital wheat gluten (one of 4 set doses, from 50 mg up to 1 g gluten) or placebo (0 mg gluten). The cookie will be prepared by a designated unblinded clinical research nurse who will not have contact with the participant. A separate clinical research nurse will provide the cookie to the participant and it will be consum
A randomised, double-blind food challenge study. Adult participants with treated coeliac disease be randomised to consume a single gluten-free cookie (the intervention) containing vital wheat gluten (one of 4 set doses, from 50 mg up to 1 g gluten) or placebo (0 mg gluten). The cookie will be prepared by a designated unblinded clinical research nurse who will not have contact with the participant. A separate clinical research nurse will provide the cookie to the participant and it will be consumed at their home. Collection of faecal samples will commence two weeks prior to the challenge (3 times per week) and, after the challenge, each stool passed will be collected for at least one week or until at least 3 samples are obtained if more than one week is required. The faecal samples will be stored frozen for later analysis using a gluten immunogenic peptide (GIP) faecal assay (ivyLISA). The challenge and monitoring will be conducted in the participant’s own home/work environment.
Sponsors
A/Professor Jason Tye-Din
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Outcome results
None listed