Safety and Tolerability of Oat Containing Gluten-free Diet

Not Applicable

Completed

• Conditions: Celiac Disease
• Interventions: Dietary Supplement: Pure, uncontaminated oats

• Registration Number: NCT02612766
• Lead Sponsor: Alfred Rusescu Institute for Mother and Child Care

Brief Summary

The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-21
• Study First Posted: 2015-11-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)
• Subject is able to fully participate in all aspects of this clinical trial

Exclusion Criteria

• Known intolerance to oats
• Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Pure, uncontaminated oats	This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats

Primary Outcome Measures

Name	Time	Method
Change in immunological activity of the disease measured by specific antibodies	After 6 weeks
Change in patient symptoms assessed by validated questionnaire	After 6 weeks

Secondary Outcome Measures

Name	Time	Method
Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire	After 6 weeks

Trial Locations

Locations (1)

"Alfred Rusescu" Institute for Mother and Child Care; 🇷🇴 Bucharest, Romania