Clinical trial NCT00808301: Oat Products in the Treatment of Coeliac Disease in Children
Official title: Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical and Nutritional Safety.
Keywords: Coeliac disease
Oat
Lead sponsor: Heinz Italia SpA
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: 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.
timeFrame: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.
Secondary outcomes:
measure: Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.
timeFrame: Product liking questionnaire after 6 months and 15 months from the beginning of the study.
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
state: CT
city: Cava de' Tirreni
country: Italy
facility: Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
state: Salerno
city: Ancona
country: Italy
facility: Università Politecnica delle Marche, Clinica Pediatrica
city: Bari
country: Italy
facility: Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
city: Bolzano
country: Italy
facility: Ospedale Centrale, Divisione di Pediatria
city: Monza
country: Italy
facility: Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
city: Roma
country: Italy
facility: Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
Study officials:
affiliation: Università Politecnica delle Marche - Clinica Pediatrica - Ancona
name: Carlo Catassi, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari
name: Ruggiero Francavilla, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Centrale di Bolzano
name: Klaus Pittschieler, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)
name: Basilio Malamisura, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera "San Gerardo" - Monza
name: Roberto Panceri, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Policlinico Umberto I, Roma
name: Maria Barbato, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele, Catania
name: Mario La Rosa, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. No abstract available. English, Spanish.
citation: 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.
citation: 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.
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. doi: 10.1067/mpd.2000.109003.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1080/00365520600863944.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1016/S0140-6736(00)02169-3.
citation: 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.