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

NCT05803408 | Recruiting

• 1 other identifier: 15964
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Better symptom control

  To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving better symptom control (change in Celiac Disease Gastrointestinal Symptom Rating Scale scores; range 15-115; lower the score, the better the outcome) at 3- and 6-month follow-up

  3-6 months

• tTG antibody levels

  To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: Change in tTG antibody levels at 6-month follow-up

  6 months

• improvement of nutritional status

  To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement of nutritional status (reduce % body fat mass)

  6 months

• improvement in quality of life (change in Celiac Disease Quality of Life scores)

  To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement in quality of life (change in Celiac Disease Quality of Life scores, 20-100, lower the score better the outcome) at 3- and 6-month follow-up

  3-6 months

• Food insecurity

  Food insecurity will be assessed through Household Food Security Survey Module (HFSSM)

  6 months

Study Arms (2)

Early introduction of gluten free oats

EXPERIMENTAL

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

Other: gluten-free oats

Late introduction of gluten free oats

ACTIVE COMPARATOR

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

Other: gluten-free oats

Interventions

gluten-free oats OTHER

Early vs late introduction of gluten free oats

Early introduction of gluten free oats; Late introduction of gluten free oats

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have already removed oats from the diet;
• History of allergic reaction to oats
• Prior assessment and education by RD on GFD
• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8S2H1, Canada

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jedid-Jah Blom, RD

  Hamilton Health Sciences Corporation

  STUDY DIRECTOR

Central Study Contacts

Nicole Chang, MD

CONTACT

6476553177; nicole.chang@medportal.ca

Ines Pinto-Sanchez, MD

CONTACT

+1 905 5259140; pintosm@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: April 7, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)