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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Gluten-free bakery products containing oatmeal.
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
Catania, CT, Italy
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, Italy
Università Politecnica delle Marche, Clinica Pediatrica
Ancona, Italy
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
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.
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.
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Bari, Italy
Ospedale Centrale, Divisione di Pediatria
Bolzano, Italy
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
Monza, Italy
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
Roma, Italy