Safety and Tolerability of Oat Containing Gluten-free Diet (SafeOatDiet)

Alfred Rusescu Institute for Mother and Child Care

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: Pure, uncontaminated oats

Study type: Interventional

Funder types: Other

Identifiers

NCT02612766

PCCA2-111/2012

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Single Arm

Other group

Description:

This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats

Treatment:

Dietary Supplement: Pure, uncontaminated oats