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RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.

Celiac Disease | Gluten Sensitivity | Gluten Enteropathy | Gluten Allergy

The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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.

Study Location

McMaster University Medical Center
McMaster University Medical Center
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Nicole Chang, MD

Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT05803408