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Oat Products in the Treatment of Coeliac Disease in Children

Primary Purpose

Clinical and Nutritional Safety.

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Gluten-free products
Sponsored by
Heinz Italia SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical and Nutritional Safety. focused on measuring Coeliac disease, Oat

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
  • Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
  • Università Politecnica delle Marche, Clinica Pediatrica
  • Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
  • Ospedale Centrale, Divisione di Pediatria
  • Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
  • Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A/B

Arm Description

This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.

Outcomes

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.

Secondary Outcome Measures

Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.

Full Information

First Posted
December 12, 2008
Last Updated
March 17, 2015
Sponsor
Heinz Italia SpA
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1. Study Identification

Unique Protocol Identification Number
NCT00808301
Brief Title
Oat Products in the Treatment of Coeliac Disease in Children
Official Title
Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinz Italia SpA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical and Nutritional Safety.
Keywords
Coeliac disease, Oat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A/B
Arm Type
Other
Arm Description
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
Intervention Type
Other
Intervention Name(s)
Gluten-free products
Other Intervention Name(s)
BiAglut
Intervention Description
Gluten-free bakery products containing oatmeal.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Catassi, Prof.
Organizational Affiliation
Università Politecnica delle Marche - Clinica Pediatrica - Ancona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruggiero Francavilla, Dr.
Organizational Affiliation
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Klaus Pittschieler, Prof.
Organizational Affiliation
Ospedale Centrale di Bolzano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Basilio Malamisura, Prof.
Organizational Affiliation
Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Panceri, Dr.
Organizational Affiliation
Azienda Ospedaliera "San Gerardo" - Monza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Barbato, Prof.
Organizational Affiliation
Azienda Policlinico Umberto I, Roma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario La Rosa, Prof.
Organizational Affiliation
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele, Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
City
Catania
State/Province
CT
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
City
Cava de' Tirreni
State/Province
Salerno
ZIP/Postal Code
84013
Country
Italy
Facility Name
Università Politecnica delle Marche, Clinica Pediatrica
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Centrale, Divisione di Pediatria
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
City
Roma
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
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Citation
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Citation
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Citation
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Oat Products in the Treatment of Coeliac Disease in Children

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