Oat Products in the Treatment of Coeliac Disease in Children

Clinical and Nutritional Safety. Clinical Trial

Official title:

Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00808301
• Other study ID #: PLA-07-01
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2008
• Last updated: March 17, 2015
• Start date: January 2009
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: Heinz Italia SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease
• Clinical and Nutritional Safety.

Intervention

Other:
• Gluten-free products
Gluten-free bakery products containing oatmeal.

Locations

Country	Name	City	State
Italy	Università Politecnica delle Marche, Clinica Pediatrica	Ancona
Italy	Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"	Bari
Italy	Ospedale Centrale, Divisione di Pediatria	Bolzano
Italy	Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"	Catania	CT
Italy	Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria	Cava de' Tirreni	Salerno
Italy	Azienda Ospedaliera "San Gerardo", Clinica Pediatrica	Monza
Italy	Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Heinz Italia SpA

Country where clinical trial is conducted

Italy, 

References & Publications (17)

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. — View Citation

Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. Review. English, Spanish. — View Citation

Fasano A, Catassi C. Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology. 2001 Feb;120(3):636-51. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004 Nov 4;351(19):2021-2. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.	Yes
Secondary	Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.		Product liking questionnaire after 6 months and 15 months from the beginning of the study.	No