Clinical and Nutritional Safety. Clinical Trial
Official title:
Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment