Celiac Disease
Conditions
Keywords
celiac disease, oat, gluten free diet
Brief summary
The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.
Interventions
DIETARY_SUPPLEMENTPure, uncontaminated oats
Sponsors
The National Research and Development Institute for Alimentary Bioresources, Bucharest
Alfred Rusescu Institute for Mother and Child Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire | After 6 weeks |
Countries
Romania
Outcome results
None listed