search
Back to results

Safety and Tolerability of Oat Containing Gluten-free Diet (SafeOatDiet)

Primary Purpose

Celiac Disease

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Pure, uncontaminated oats
Sponsored by
Alfred Rusescu Institute for Mother and Child Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, oat, gluten free diet

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Alfred Rusescu" Institute for Mother and Child Care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in immunological activity of the disease measured by specific antibodies
Change in patient symptoms assessed by validated questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2015
Last Updated
August 2, 2017
Sponsor
Alfred Rusescu Institute for Mother and Child Care
Collaborators
The National Research and Development Institute for Alimentary Bioresources, Bucharest
search

1. Study Identification

Unique Protocol Identification Number
NCT02612766
Brief Title
Safety and Tolerability of Oat Containing Gluten-free Diet
Acronym
SafeOatDiet
Official Title
SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alfred Rusescu Institute for Mother and Child Care
Collaborators
The National Research and Development Institute for Alimentary Bioresources, Bucharest

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
celiac disease, oat, gluten free diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats
Intervention Type
Dietary Supplement
Intervention Name(s)
Pure, uncontaminated oats
Primary Outcome Measure Information:
Title
Change in immunological activity of the disease measured by specific antibodies
Time Frame
After 6 weeks
Title
Change in patient symptoms assessed by validated questionnaire
Time Frame
After 6 weeks
Secondary Outcome Measure Information:
Title
Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire
Time Frame
After 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
"Alfred Rusescu" Institute for Mother and Child Care
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
24201240
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.
Results Reference
background
PubMed Identifier
24264227
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.
Results Reference
background
PubMed Identifier
23379438
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.
Results Reference
background
PubMed Identifier
24916557
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.
Results Reference
background
PubMed Identifier
24964993
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.
Results Reference
background
PubMed Identifier
24661128
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.
Results Reference
background

Learn more about this trial

Safety and Tolerability of Oat Containing Gluten-free Diet

We'll reach out to this number within 24 hrs