Oat Products in the Treatment of Coeliac Disease in Children
NCT ID: NCT00808301
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2009-01-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Gluten-free products
Gluten-free bakery products containing oatmeal.
Interventions
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Gluten-free products
Gluten-free bakery products containing oatmeal.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
4 Years
14 Years
ALL
No
Sponsors
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Heinz Italia SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Carlo Catassi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Università Politecnica delle Marche - Clinica Pediatrica - Ancona
Ruggiero Francavilla, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari
Klaus Pittschieler, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Centrale di Bolzano
Basilio Malamisura, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)
Roberto Panceri, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera "San Gerardo" - Monza
Maria Barbato, Prof.
Role: PRINCIPAL_INVESTIGATOR
Azienda Policlinico Umberto I, Roma
Mario La Rosa, Prof.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele, Catania
Locations
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Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
Catania, CT, Italy
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, 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 Ospedaliera "San Gerardo", Clinica Pediatrica
Monza, , Italy
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
Roma, , Italy
Countries
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References
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Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. No abstract available. 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. doi: 10.1053/gast.2001.22123.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PLA-07-01
Identifier Type: -
Identifier Source: org_study_id
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