Oat Products in the Treatment of Coeliac Disease in Children
This trial is active, not recruiting.
|Condition||clinical and nutritional safety.|
|Sponsor||Heinz Italia SpA|
|Start date||January 2009|
|End date||July 2014|
|Trial size||300 participants|
|Trial identifier||NCT00808301, PLA-07-01|
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|
|Catania, Italy||Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"||no longer recruiting|
|Cava de' Tirreni, Italy||Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria||no longer recruiting|
|Ancona, Italy||Università Politecnica delle Marche, Clinica Pediatrica||no longer recruiting|
|Bari, Italy||Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"||no longer recruiting|
|Bolzano, Italy||Ospedale Centrale, Divisione di Pediatria||no longer recruiting|
|Monza, Italy||Azienda Ospedaliera "San Gerardo", Clinica Pediatrica||no longer recruiting|
|Roma, Italy||Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
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.
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).
|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.|
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