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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Better symptom control

Food insecurity

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

+2 more

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,266 Total Patients Enrolled

4 Trials studying Celiac Disease

240 Patients Enrolled for Celiac Disease

Jedid-Jah Blom, RDStudy DirectorHamilton Health Sciences Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research currently accessible to participants?

"Yes, clinicaltrials.gov states that enrolment for this trial is ongoing. The initial post was made on June 1st 2023 and the listing has been updated as of October 18th 2023."

Answered by AI

What is the capacity of subjects for this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that the study posted on June 1st 2023 is actively searching for participants, with a target of 50 individuals at one medical facility. The trial was last updated 18th October 2023."

Answered by AI