Clinical trial NCT02612766: Safety and Tolerability of Oat Containing Gluten-free Diet
Official title: SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: celiac disease
oat
gluten free diet
Lead sponsor: Alfred Rusescu Institute for Mother and Child Care
Sponsor class: OTHER
Collaborators: name: The National Research and Development Institute for Alimentary Bioresources, Bucharest
First posted: 2015-11-24
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in immunological activity of the disease measured by specific antibodies
timeFrame: After 6 weeks
measure: Change in patient symptoms assessed by validated questionnaire
timeFrame: After 6 weeks
Secondary outcomes:
measure: Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire
timeFrame: After 6 weeks
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Alfred Rusescu" Institute for Mother and Child Care
Study officials:
References:
citation: Kaukinen K, Collin P, Huhtala H, Maki M. Long-term consumption of oats in adult celiac disease patients. Nutrients. 2013 Nov 6;5(11):4380-9. doi: 10.3390/nu5114380.
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.
citation: 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.
citation: Tapsas D, Falth-Magnusson K, Hogberg L, Hammersjo JA, Hollen 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.
citation: Sjoberg V, Hollen E, Pietz G, Magnusson KE, Falth-Magnusson K, Sundstrom M, Holmgren Peterson K, Sandstrom O, Hernell O, Hammarstrom S, Hogberg L, Hammarstrom ML. Noncontaminated dietary oats may hamper normalization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol. 2014 Jun 26;5(6):e58. doi: 10.1038/ctg.2014.9.
citation: Tjellstrom B, Stenhammar L, Sundqvist T, Falth-Magnusson K, Hollen E, Magnusson KE, Norin E, Midtvedt T, Hogberg 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.