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Sponsored by: |
Plada Industriale Srl |
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Information provided by: | Plada Industriale Srl |
ClinicalTrials.gov Identifier: | NCT00808301 |
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 |
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Clinical and Nutritional Safety. |
Other: Gluten-free products |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
Official Title: | Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children |
Estimated Enrollment: | 300 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A/B
This is a cross-over design, i.e. each patient is treated with either oat or control products in different times.
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Other: Gluten-free products
Gluten-free bakery products containing oatmeal.
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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.
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:
Exclusion Criteria:
Contact: Dr Elisabetta Vacca | 0039-02-52563235 | elisabetta.vacca@it.hjheinz.com |
Italy | |
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" | Not yet recruiting |
Bari, Italy, 70124 | |
Contact: Ruggiero Francavilla, Dr 00390805592847 rfrancavilla@libero.it | |
Principal Investigator: Ruggiero Francavilla, Dr. | |
Ospedale Centrale, Divisione di Pediatria | Not yet recruiting |
Bolzano, Italy, 39100 | |
Contact: Klaus Pittschieler, Prof 00390471908648 Klaus.Pittschieler@asbz.it | |
Principal Investigator: Klaus Pittschieler, Prof. | |
Italy, Milano | |
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica | Not yet recruiting |
Monza, Milano, Italy, 20052 | |
Contact: Roberto Panceri, Dr 00390392333279 roberto.panceri@pediatriamonza.it | |
Principal Investigator: Roberto Panceri, Dr. | |
Italy, Salerno | |
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. |
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 (MI) |
Responsible Party: | Università Politecnica delle Marche, Clinica Pediatrica, 60123 Ancona, Italy ( Prof. Carlo Catassi ) |
Study ID Numbers: | PLA-07-01 |
Study First Received: | December 12, 2008 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00808301 |
Health Authority: | Italy: Ethics Committee |
Coeliac disease Oat |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases |