Oat Products in the Treatment of Coeliac Disease in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heinz Italia SpA
ClinicalTrials.gov Identifier:
NCT00808301
First received: December 12, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Clinical and Nutritional Safety.
Other: Gluten-free products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children

Resource links provided by NLM:


Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A/B
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
Other: Gluten-free products
Gluten-free bakery products containing oatmeal.
Other Name: BiAglut

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.

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808301

Locations
Italy
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
Catania, CT, Italy, 95124
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, Italy, 84013
Università Politecnica delle Marche, Clinica Pediatrica
Ancona, Italy, 60123
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
Bari, Italy, 70124
Ospedale Centrale, Divisione di Pediatria
Bolzano, Italy, 39100
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
Monza, Italy, 20052
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
Roma, Italy, 00161
Sponsors and Collaborators
Heinz Italia SpA
Investigators
Principal Investigator: Carlo Catassi, Prof. Università Politecnica delle Marche - Clinica Pediatrica - Ancona
Principal Investigator: Ruggiero Francavilla, Dr. Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari
Principal Investigator: Klaus Pittschieler, Prof. Ospedale Centrale di Bolzano
Principal Investigator: Basilio Malamisura, Prof. Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)
Principal Investigator: Roberto Panceri, Dr. Azienda Ospedaliera "San Gerardo" - Monza
Principal Investigator: Maria Barbato, Prof. Azienda Policlinico Umberto I - Roma
Principal Investigator: Mario La Rosa, Prof. Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele" - Catania
  More Information

Publications:

Responsible Party: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT00808301     History of Changes
Other Study ID Numbers: PLA-07-01
Study First Received: December 12, 2008
Last Updated: August 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:
Coeliac disease
Oat

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014