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NCT02612766 Clinical Trial

Safety and Tolerability of Oat Containing Gluten-free Diet

Celiac Disease Clinical Trial

— SafeOatDiet  

Official title:
SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02612766
Other study ID # PCCA2-111/2012
Secondary ID
Status Completed
Phase N/A
First received November 11, 2015
Last updated August 2, 2017
Start date November 2015
Est. completion date December 2016

Study information
Verified date August 2017
Source Alfred Rusescu Institute for Mother and Child Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 4 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Pure, uncontaminated oats

Locations
Country Name City State
Romania "Alfred Rusescu" Institute for Mother and Child Care Bucharest

Sponsors (2)
Lead Sponsor Collaborator
Alfred Rusescu Institute for Mother and Child Care The National Research and Development Institute for Alimentary Bioresources, Bucharest

Country where clinical trial is conducted

Romania, 

References & Publications (6)

Cooper SE, Kennedy NP, Mohamed BM, Abuzakouk M, Dunne J, Byrne G, McDonald G, Davies A, Edwards C, Kelly J, Feighery CF. Immunological indicators of coeliac disease activity are not altered by long-term oats challenge. Clin Exp Immunol. 2013 Mar;171(3):313-8. doi: 10.1111/cei.12014. — View Citation

Gatti S, Caporelli N, Galeazzi T, Francavilla R, Barbato M, Roggero P, Malamisura B, Iacono G, Budelli A, Gesuita R, Catassi C, Lionetti E. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study. Nutrients. 2013 Nov 20;5(11):4653-64. doi: 10.3390/nu5114653. — View Citation

Kaukinen K, Collin P, Huhtala H, Mäki M. Long-term consumption of oats in adult celiac disease patients. Nutrients. 2013 Nov 6;5(11):4380-9. doi: 10.3390/nu5114380. — View Citation

Sjöberg V, Hollén E, Pietz G, Magnusson KE, Fälth-Magnusson K, Sundström M, Holmgren Peterson K, Sandström O, Hernell O, Hammarström S, Högberg L, Hammarström ML. Noncontaminated dietary oats may hamper normalization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol. 2014 Jun 26;5:e58. doi: 10.1038/ctg.2014.9. — View Citation

Tapsas D, Fälth-Magnusson K, Högberg L, Hammersjö JÅ, Hollén E. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long-term follow-up study. Nutr Res. 2014 May;34(5):436-41. doi: 10.1016/j.nutres.2014.04.006. Epub 2014 Apr 18. — View Citation

Tjellström B, Stenhammar L, Sundqvist T, Fälth-Magnusson K, Hollén E, Magnusson KE, Norin E, Midtvedt T, Högberg L. The effects of oats on the function of gut microflora in children with coeliac disease. Aliment Pharmacol Ther. 2014 May;39(10):1156-60. doi: 10.1111/apt.12707. Epub 2014 Mar 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in immunological activity of the disease measured by specific antibodies After 6 weeks
Primary Change in patient symptoms assessed by validated questionnaire After 6 weeks
Secondary Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire After 6 weeks
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