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Timing of Gluten-free Oats Introduction for Celiac Disease

N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Unwillingness or inability to commit to study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how early vs. late introduction of gluten-free oats can help improve gut symptoms, nutrition status, celiac activity and quality of life in celiac patients. Questionnaires, tests, physical exams and dietary analysis will be used.

Who is the study for?
This trial is for people who've been recently diagnosed with celiac disease, confirmed by specific blood tests and intestinal biopsies. They should have started a gluten-free diet within the last three months but haven't yet received detailed dietary guidance or removed oats from their diet.
What is being tested?
The study is testing if introducing gluten-free oats early in the diet of new celiac patients affects gut symptoms, nutrition, celiac activity, and life quality differently than introducing them later. It's a small-scale pilot to prepare for a larger study.
What are the potential side effects?
Since this trial involves eating gluten-free oats, side effects may include potential oat intolerance reactions like digestive discomfort or allergic responses in sensitive individuals.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing and able to follow the study's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Better symptom control
Food insecurity
improvement in quality of life (change in Celiac Disease Quality of Life scores)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early introduction of gluten free oatsExperimental Treatment1 Intervention
Early introduction of oats (starting GF oats immediately after the diagnosis, within 3 months)
Group II: Late introduction of gluten free oatsActive Control1 Intervention
Late introduction of oats (starting GF oats 6 months after diagnosis of celiac disease)

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,209 Total Patients Enrolled
4 Trials studying Celiac Disease
240 Patients Enrolled for Celiac Disease
Jedid-Jah Blom, RDStudy DirectorHamilton Health Sciences Corporation
~0 spots leftby Dec 2024
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