Oat Products in the Treatment of Coeliac Disease in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children

Conditions
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Clinical and Nutritional Safety.

Intervention / Treatment
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* Other: Gluten-free products


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A/B<br>This is a cross-over design, i.e. each patient is treated with either oat or control products in different times. | Other: Gluten-free products<br>* Gluten-free bakery products containing oatmeal.<br>* Other names: BiAglut;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire. |  | Product liking questionnaire after 6 months and 15 months from the beginning of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coeliac disease, Oat