Status:
UNKNOWN
Oat Products in the Treatment of Coeliac Disease in Children
Lead Sponsor:
Heinz Italia SpA
Conditions:
Clinical and Nutritional Safety.
Eligibility:
All Genders
4-14 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00808301
Start Date
January 1 2009
End Date
October 1 2015
Last Update
March 18 2015
Active Locations (7)
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1
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
Catania, CT, Italy, 95124
2
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, Italy, 84013
3
Università Politecnica delle Marche, Clinica Pediatrica
Ancona, Italy, 60123
4
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
Bari, Italy, 70124