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Oat Products in the Treatment of Coeliac Disease in Children
This study is not yet open for participant recruitment.
Verified by Plada Industriale Srl, December 2008
Sponsored by: Plada Industriale Srl
Information provided by: Plada Industriale Srl
ClinicalTrials.gov Identifier: NCT00808301
  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

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources
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

Further study details as provided by Plada Industriale Srl:

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, 12, 15, 18 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 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: July 2011
Estimated Primary Completion Date: April 2011 (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.

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
Criteria

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

Contacts
Contact: Dr Elisabetta Vacca 0039-02-52563235 elisabetta.vacca@it.hjheinz.com

Locations
Italy
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
Italy, Milano
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
Monza, Milano, Italy, 20052
Italy, Salerno
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, Italy, 84013
Sponsors and Collaborators
Plada Industriale Srl
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 (MI)
  More Information

Publications:
Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. Review. English, Spanish. No abstract available.
Fasano A, Catassi C. Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology. 2001 Feb;120(3):636-51. Review.
Reunala T, Collin P, Holm K, Pikkarainen P, Miettinen A, Vuolteenaho N, Mäki M. Tolerance to oats in dermatitis herpetiformis. Gut. 1998 Oct;43(4):490-3.
Hoffenberg EJ, Haas J, Drescher A, Barnhurst R, Osberg I, Bao F, Eisenbarth G. A trial of oats in children with newly diagnosed celiac disease. J Pediatr. 2000 Sep;137(3):361-6.
Janatuinen EK, Kemppainen TA, Julkunen RJ, Kosma VM, Mäki M, Heikkinen M, Uusitupa MI. No harm from five year ingestion of oats in coeliac disease. Gut. 2002 Mar;50(3):332-5.
Størsrud S, Olsson M, Arvidsson Lenner R, Nilsson LA, Nilsson O, Kilander A. Adult coeliac patients do tolerate large amounts of oats. Eur J Clin Nutr. 2003 Jan;57(1):163-9.
Lundin KE, Nilsen EM, Scott HG, Løberg EM, Gjøen A, Bratlie J, Skar V, Mendez E, Løvik A, Kett K. Oats induced villous atrophy in coeliac disease. Gut. 2003 Nov;52(11):1649-52.
Högberg L, Laurin P, Fälth-Magnusson K, Grant C, Grodzinsky E, Jansson G, Ascher H, Browaldh L, Hammersjö JA, Lindberg E, Myrdal U, Stenhammar L. Oats to children with newly diagnosed coeliac disease: a randomised double blind study. Gut. 2004 May;53(5):649-54.
Arentz-Hansen H, Fleckenstein B, Molberg Ø, Scott H, Koning F, Jung G, Roepstorff P, Lundin KE, Sollid LM. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med. 2004 Oct;1(1):e1. Epub 2004 Oct 19.
Holm K, Mäki M, Vuolteenaho N, Mustalahti K, Ashorn M, Ruuska T, Kaukinen K. Oats in the treatment of childhood coeliac disease: a 2-year controlled trial and a long-term clinical follow-up study. Aliment Pharmacol Ther. 2006 May 15;23(10):1463-72.
Peräaho M, Collin P, Kaukinen K, Kekkonen L, Miettinen S, Mäki M. Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc. 2004 Jul;104(7):1148-50.
Garsed K, Scott BB. Can oats be taken in a gluten-free diet? A systematic review. Scand J Gastroenterol. 2007 Feb;42(2):171-8. Review.
Størsrud S, Hulthén LR, Lenner RA. Beneficial effects of oats in the gluten-free diet of adults with special reference to nutrient status, symptoms and subjective experiences. Br J Nutr. 2003 Jul;90(1):101-7.
Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004 Nov 4;351(19):2021-2. No abstract available.
Hernando A, Mujico JR, Juanas D, Méndez E. Confirmation of the cereal type in oat products highly contaminated with gluten. J Am Diet Assoc. 2006 May;106(5):665; discussion 665-6. No abstract available.
Hollén E, Högberg L, Stenhammar L, Fälth-Magnusson K, Magnusson KE. Antibodies to oat prolamines (avenins) in children with coeliac disease. Scand J Gastroenterol. 2003 Jul;38(7):742-6.
Fasano A, Not T, Wang W, Uzzau S, Berti I, Tommasini A, Goldblum SE. Zonulin, a newly discovered modulator of intestinal permeability, and its expression in coeliac disease. Lancet. 2000 Apr 29;355(9214):1518-9.

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: December 12, 2008
ClinicalTrials.gov Identifier: NCT00808301  
Health Authority: Italy: Ethics Committee

Keywords provided by Plada Industriale Srl:
Coeliac disease
Oat

Study placed in the following topic categories:
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes
Celiac Disease
Metabolic disorder
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009