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

August 2, 2017 updated by: Alfred Rusescu Institute for Mother and Child Care

SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • "Alfred Rusescu" Institute for Mother and Child Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats
Dietary supplement: Pure, uncontaminated oats

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in immunological activity of the disease measured by specific antibodies
Time Frame: After 6 weeks
After 6 weeks
Change in patient symptoms assessed by validated questionnaire
Time Frame: After 6 weeks
After 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire
Time Frame: After 6 weeks
After 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfred Rusescu Institute for Mother and Child Care

Collaborators

The National Research and Development Institute for Alimentary Bioresources, Bucharest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 21, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCCA2-111/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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