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Oat Products in the Treatment of Coeliac Disease in Children

NCT00808301 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

  • Clinical and Nutritional Safety.

Interventions

OTHER

Gluten-free products

Gluten-free bakery products containing oatmeal.

Sponsors & Collaborators

  • Heinz Italia SpA

    lead INDUSTRY

Principal Investigators

  • Carlo Catassi, Prof. · Università Politecnica delle Marche - Clinica Pediatrica - Ancona

  • Ruggiero Francavilla, Dr. · Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari

  • Klaus Pittschieler, Prof. · Ospedale Centrale di Bolzano

  • Basilio Malamisura, Prof. · Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)

  • Roberto Panceri, Dr. · Azienda Ospedaliera "San Gerardo" - Monza

  • Maria Barbato, Prof. · Azienda Policlinico Umberto I, Roma

  • Mario La Rosa, Prof. · Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele, Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-07-31
Completion
2015-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808301 on ClinicalTrials.gov