Safety and Tolerability of Oat Containing Gluten-free Diet

NCT02612766 | Completed

• 1 other identifier: PCCA2-111/2012
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Celiac Disease

Keywords

celiac disease; oat; gluten free diet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  After 6 weeks

Study Arms (1)

Single Arm

OTHER

This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats

Dietary Supplement: Pure, uncontaminated oats

Interventions

Pure, uncontaminated oats DIETARY_SUPPLEMENT

Single Arm

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfred Rusescu Institute for Mother and Child Care: lead
• The National Research and Development Institute for Alimentary Bioresources, Bucharest: collaborator

Study Sites (1)

"Alfred Rusescu" Institute for Mother and Child Care

Bucharest, Romania

Location

Related Publications (6)

• 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.

  PMID: 24201240 BACKGROUND

• 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.

  PMID: 24264227 BACKGROUND

• 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.

  PMID: 23379438 BACKGROUND

• 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.

  PMID: 24916557 BACKGROUND

• 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.

  PMID: 24964993 BACKGROUND

• 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.

  PMID: 24661128 BACKGROUND

MeSH Terms

Conditions

Celiac Disease; Gyrate Atrophy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

RO (1)