Overview

This trial is active, not recruiting.

Condition clinical and nutritional safety.
Treatment gluten-free products
Sponsor Heinz Italia SpA
Start date January 2009
End date July 2014
Trial size 300 participants
Trial identifier NCT00808301, PLA-07-01

Summary

In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.

The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
gluten-free products BiAglut
Gluten-free bakery products containing oatmeal.

Primary Outcomes

Measure
Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions.
time frame: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.

Secondary Outcomes

Measure
Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.
time frame: Product liking questionnaire after 6 months and 15 months from the beginning of the study.

Eligibility Criteria

Male or female participants from 4 years up to 14 years old.

Inclusion Criteria: the study will include patients aged between 4 and 14, under treatment with a gluten-free diet for coeliac disease (bioptic diagnosis) for at least two years. Exclusion Criteria: diagnosis not confirmed by intestinal biopsy, cases with little adherence to the treatment (anti-tTG positive at basal evaluation), cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric IgA deficit, cases with associated diseases (es. diabetes type 1).

Additional Information

Official title Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
Principal investigator Carlo Catassi, Prof.
Description Several clinical trials have demonstrated that most celiac patients, both of pediatric and of adult age, can take medium-high quantity of oat (50-100 g/day), without any negative clinical effects. In a small number of cases intestinal dyspeptic disorders, especially meteorism, can be observed, particularly during the first weeks of oat intake. They are generally without clinical significance because they are a consequence of the increased fibre intake. There are only few cases of "true" oats intolerance. The addition of oat improves the nutritional quality of the gluten-free diet, particularly due to the increased intake of fibre and some oligoelements (iron, zinc, tiamin, pholates) and expands the spectrum of food choices. In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years. For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease, the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed. The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Heinz Italia SpA.