Oat Products in the Treatment of Coeliac Disease in Children

NCT00808301 | Unknown

• 1 other identifier: PLA-07-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Clinical and Nutritional Safety.

Keywords

Coeliac disease; Oat

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

A/B

OTHER

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

Interventions

Gluten-free products OTHER

Gluten-free bakery products containing oatmeal.

Also known as: BiAglut

A/B

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Heinz Italia SpA: lead

Study Sites (7)

Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"

Catania, CT, 95124, Italy

Location

Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria

Cava de' Tirreni, Salerno, 84013, Italy

Location

Università Politecnica delle Marche, Clinica Pediatrica

Ancona, 60123, Italy

Location

Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"

Bari, 70124, Italy

Location

Ospedale Centrale, Divisione di Pediatria

Bolzano, 39100, Italy

Location

Azienda Ospedaliera "San Gerardo", Clinica Pediatrica

Monza, 20052, Italy

Location

Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica

Roma, 00161, Italy

Location

Related Publications (18)

• Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. No abstract available. English, Spanish.

  PMID: 15954735 BACKGROUND

• Fasano A, Catassi C. Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology. 2001 Feb;120(3):636-51. doi: 10.1053/gast.2001.22123.

  PMID: 11179241 BACKGROUND

• Reunala T, Collin P, Holm K, Pikkarainen P, Miettinen A, Vuolteenaho N, Maki M. Tolerance to oats in dermatitis herpetiformis. Gut. 1998 Oct;43(4):490-3. doi: 10.1136/gut.43.4.490.

  PMID: 9824575 BACKGROUND

• 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. doi: 10.1067/mpd.2000.109003.

  PMID: 10969261 BACKGROUND

• Janatuinen EK, Kemppainen TA, Julkunen RJ, Kosma VM, Maki M, Heikkinen M, Uusitupa MI. No harm from five year ingestion of oats in coeliac disease. Gut. 2002 Mar;50(3):332-5. doi: 10.1136/gut.50.3.332.

  PMID: 11839710 BACKGROUND

• Storsrud 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. doi: 10.1038/sj.ejcn.1601525.

  PMID: 12548312 BACKGROUND

• Lundin KE, Nilsen EM, Scott HG, Loberg EM, Gjoen A, Bratlie J, Skar V, Mendez E, Lovik A, Kett K. Oats induced villous atrophy in coeliac disease. Gut. 2003 Nov;52(11):1649-52. doi: 10.1136/gut.52.11.1649.

  PMID: 14570737 BACKGROUND

• Hogberg L, Laurin P, Falth-Magnusson K, Grant C, Grodzinsky E, Jansson G, Ascher H, Browaldh L, Hammersjo 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. doi: 10.1136/gut.2003.026948.

  PMID: 15082581 BACKGROUND

• Arentz-Hansen H, Fleckenstein B, Molberg O, 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. doi: 10.1371/journal.pmed.0010001. Epub 2004 Oct 19.

  PMID: 15526039 BACKGROUND

• Holm K, Maki 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. doi: 10.1111/j.1365-2036.2006.02908.x.

  PMID: 16669961 BACKGROUND

• Peraaho M, Collin P, Kaukinen K, Kekkonen L, Miettinen S, Maki M. Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc. 2004 Jul;104(7):1148-50. doi: 10.1016/j.jada.2004.04.025.

  PMID: 15215774 BACKGROUND

• 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. doi: 10.1080/00365520600863944.

  PMID: 17327936 BACKGROUND

• Storsrud S, Hulthen 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. doi: 10.1079/bjn2003872.

  PMID: 12844381 BACKGROUND

• Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004 Nov 4;351(19):2021-2. doi: 10.1056/NEJM200411043511924. No abstract available.

  PMID: 15525734 BACKGROUND

• Hernando A, Mujico JR, Juanas D, Mendez 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. doi: 10.1016/j.jada.2006.03.024. No abstract available.

  PMID: 16647318 BACKGROUND

• Hollen E, Hogberg L, Stenhammar L, Falth-Magnusson K, Magnusson KE. Antibodies to oat prolamines (avenins) in children with coeliac disease. Scand J Gastroenterol. 2003 Jul;38(7):742-6. doi: 10.1080/00365520310003156.

  PMID: 12889560 BACKGROUND

• 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. doi: 10.1016/S0140-6736(00)02169-3.

  PMID: 10801176 BACKGROUND

• Lionetti E, Gatti S, Galeazzi T, Caporelli N, Francavilla R, Cucchiara S, Roggero P, Malamisura B, Iacono G, Tomarchio S, Kleon W, Restani P, Brusca I, Budelli A, Gesuita R, Carle F, Catassi C. Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial. J Pediatr. 2018 Mar;194:116-122.e2. doi: 10.1016/j.jpeds.2017.10.062.

  PMID: 29478494 DERIVED

MeSH Terms

Conditions

Celiac Disease; Gyrate Atrophy

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Eye Diseases, Hereditary; Eye Diseases; Choroid Diseases; Uveal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

IT (7)