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Completed

NCT Number: NCT02612766

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.

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Key information

Conditions

Celiac Disease Choroid Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Eye Diseases Eye Diseases, Hereditary Gastrointestinal Diseases Genetic Diseases, Inborn Gyrate Atrophy Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Uveal Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Alfred Rusescu" Institute for Mother and Child Care

Bucharest, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pure, uncontaminated oats

Dietary Supplement

Primary outcomes

  1. Change in immunological activity of the disease measured by specific antibodies

    Time frame: After 6 weeks

  2. Change in patient symptoms assessed by validated questionnaire

    Time frame: After 6 weeks

Secondary outcomes

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

    Time frame: After 6 weeks

Sponsors and collaborators

Lead sponsor

Alfred Rusescu Institute for Mother and Child Care

Other

Collaborators

  • The National Research and Development Institute for Alimentary Bioresources, Bucharest

Registry information

Acronym: SafeOatDiet

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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