Comparing the timing of gluten-free oats introduction in newly diagnosed celiac disease patients

A Randomized Controlled Trial to Evaluate Effect of Late vs Early Introduction of Gluten-free Oats on Symptomatic, Serologic and Disease Activity in Patients With Newly Diagnosed Celiac Disease.

This study tests whether introducing gluten-free oats early or late in the diet helps people newly diagnosed with celiac disease feel better and improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McMaster University (other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT05803408 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effects of introducing gluten-free oats either early or late in the diet of patients recently diagnosed with celiac disease. Participants will be monitored for gut symptoms, nutritional status, celiac activity, and quality of life through questionnaires and clinical assessments. The study will also involve physical examinations and dietary analysis by a dietitian to ensure comprehensive data collection. The goal is to determine the feasibility of a larger study and gather preliminary data on the optimal timing for oat introduction in the diet of these patients.

Who should consider this trial

Good fit: Ideal candidates are individuals who have been recently diagnosed with celiac disease and are within three months of starting a gluten-free diet.

Not a fit: Patients who have already removed oats from their diet or have a history of allergic reactions to oats may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help optimize dietary recommendations for patients with celiac disease, potentially improving their quality of life.

How similar studies have performed: While there is limited evidence on the timing of oat introduction in celiac disease, this approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Recent diagnosis of CeD (within 3 months of starting a GFD) based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides IgG or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater). The allowance of 3 months is related to 1) the time lag between tTG and confirmatory EGD testing in clinical practice and 2) the time lag between diagnosis and dietitian assessment, which will increase likelihood of achieving a strict GFD.

Exclusion Criteria:

1. Have already removed oats from the diet;
2. History of allergic reaction to oats
3. Prior assessment and education by RD on GFD
4. Unwillingness or inability to commit to study procedures \*Patients receiving antibiotics or probiotics within a month will be allowed to participate, however, this will be documented for future microbiota analysis.

Where this trial is running

Hamilton, Ontario

• McMaster University Medical Center — Hamilton, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Nicole Chang, MD

Conditions: Celiac Disease, Gluten Sensitivity, Gluten Allergy, Gluten Enteropathy