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Oat Products in the Treatment of Coeliac Disease in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Heinz Italia SpA.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808301
First Posted: December 15, 2008
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heinz Italia SpA
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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. ]

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. ]

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: October 2015
Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. Review. English, Spanish.
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.
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.
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: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT00808301     History of Changes
Other Study ID Numbers: PLA-07-01
First Submitted: December 12, 2008
First Posted: December 15, 2008
Last Update Posted: March 18, 2015
Last Verified: March 2015

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


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