Oat Products in the Treatment of Coeliac Disease in Children
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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 |
- 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, 12, 15, 18 months from the beginning of the study. ] [ Designated as safety issue: Yes ]
- Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire. [ Time Frame: Product liking questionnaire after 6 months and 18 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 2013 |
| Estimated Primary Completion Date: | July 2013 (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: | 3 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: the study will include two groups of celiac subjects:
- Patients aged between 3 and 14,newly diagnosed for coeliac disease which is confirmed by intestinal biopsy
- 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:
- For group a) diagnosis not confirmed by intestinal biopsy, cases already under treatment with gluten-free diet, cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric IgA deficit, cases with associated diseases (es. diabetes type 1)
- or group b): 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| Contact: Dr Budelli Andrea | 0039-02-52563332 | andrea.budelli@it.hjheinz.com |
| Italy | |
| Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele" | Recruiting |
| Catania, CT, Italy, 95124 | |
| Contact: Mario La Rosa, Prof. 0039 095 3782424 mlarosa@unict.it | |
| Principal Investigator: Mario La Rosa, Prof. | |
| Sub-Investigator: Elena Lionetti, Dr. | |
| Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria | Recruiting |
| Cava de' Tirreni, Salerno, Italy, 84013 | |
| Contact: Basilio Malamisura, Prof. 00390894455385 basiliomalamisura@virgilio.it | |
| Principal Investigator: Basilio Malamisura, Prof. | |
| Università Politecnica delle Marche, Clinica Pediatrica | Recruiting |
| Ancona, Italy, 60123 | |
| Contact: Carlo Catassi, Prof 00390715962364 catassi@tin.it | |
| Principal Investigator: Carlo Catassi, Prof. | |
| Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" | Recruiting |
| Bari, Italy, 70124 | |
| Contact: Ruggiero Francavilla, Dr 00390805592847 rfrancavilla@libero.it | |
| Principal Investigator: Ruggiero Francavilla, Dr. | |
| Ospedale Centrale, Divisione di Pediatria | Recruiting |
| Bolzano, Italy, 39100 | |
| Contact: Klaus Pittschieler, Prof 00390471908648 Klaus.Pittschieler@asbz.it | |
| Principal Investigator: Klaus Pittschieler, Prof. | |
| Azienda Ospedaliera "San Gerardo", Clinica Pediatrica | Recruiting |
| Monza, Italy, 20052 | |
| Contact: Roberto Panceri, Dr 00390392333279 r.panceri@hsgerardo.org | |
| Principal Investigator: Roberto Panceri, Dr. | |
| Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica | Recruiting |
| Roma, Italy, 00161 | |
| Contact: Maria Barbato, Prof. 00390649979257 Maria.Barbato@uniroma1.it | |
| Principal Investigator: Maria Barbato, Prof. | |
| 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: | April 5, 2012 |
| 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 May 16, 2013