Recruiting

Gluten-free Oats

Sponsor:

McMaster University

Code:

NCT05803408

Conditions

Celiac Disease

Gluten Sensitivity

Gluten Allergy

Gluten Enteropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

gluten-free oats

Study Details

Brief summary:

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.

Conditions

Celiac Disease

Gluten Sensitivity

Gluten Allergy

Gluten Enteropathy

Study ID

NCT05803408

Start date

Jun 1, 2023

Status verified date

Mar, 2024

Completion date

May, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Early introduction of gluten free oats

Early introduction of oats (starting GF oats immediately after the diagnosis, within 3 months)

active comparator: Late introduction of gluten free oats

Late introduction of oats (starting GF oats 6 months after diagnosis of celiac disease)

Interventions

gluten-free oats

Early vs late introduction of gluten free oats

Primary outcome measure

  • Better symptom control [ Time Frame: 3-6 months ]
  • tTG antibody levels [ Time Frame: 6 months ]
  • improvement of nutritional status [ Time Frame: 6 months ]
  • improvement in quality of life (change in Celiac Disease Quality of Life scores) [ Time Frame: 3-6 months ]
  • Food insecurity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

McMaster University Medical Center

Recruiting

Hamilton, Ontario, Canada, L8S2H1

More Information

Sponsor

McMaster University

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by McMaster University on 2024-03-15.