Safety and Tolerability of Oat Containing Gluten-free Diet

N/ACompletedNCT02612766

Alfred Rusescu Institute for Mother and Child Care25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Celiac Disease

Interventions

Pure, uncontaminated oatsDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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

Locations (1)

"Alfred Rusescu" Institute for Mother and Child Care

Bucharest, Romania

Outcomes

Primary Outcomes

Change in immunological activity of the disease measured by specific antibodies

Time frame: After 6 weeks

Change in patient symptoms assessed by validated questionnaire

Time frame: After 6 weeks

Secondary Outcomes

Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire

Time frame: After 6 weeks

Data from ClinicalTrials.gov

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