Oat Products in the Treatment of Coeliac Disease in Children
- Conditions
- Clinical and Nutritional Safety.
- Interventions
- Other: Gluten-free products
- Registration Number
- NCT00808301
- Lead Sponsor
- Heinz Italia SpA
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A/B Gluten-free products This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (7)
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
🇮🇹Bari, Italy
Ospedale Centrale, Divisione di Pediatria
🇮🇹Bolzano, Italy
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
🇮🇹Catania, CT, Italy
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
🇮🇹Monza, Italy
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
🇮🇹Cava de' Tirreni, Salerno, Italy
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
🇮🇹Roma, Italy
Università Politecnica delle Marche, Clinica Pediatrica
🇮🇹Ancona, Italy