CoChat
Sign Up
Cited by 49Celiac Disease Research and ManagementEosinophilic EsophagitisFood composition and properties

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial

Open access
Lionetti, Elena, Gatti, Simona, Galeazzi, Tiziana, Caporelli, Nicole, Francavilla, Ruggiero, Cucchiara, Salvatore, Roggero, Paola, Malamisura, Basilio +9 more·2018·The Journal of Pediatrics
DOI 10.1016/j.jpeds.2017.10.062
Open this paper in CoChat — free accountOpen PDF

Abstract

Objective To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease. Study design This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic. Results After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089). Conclusions Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease. Trial registration ClinicalTrials.gov: NCT00808301.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.jpeds.2017.10.062

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

No references could be resolved yet.

Research works printed but not linked: 40

  1. Fasano A, Catassi C. Celiac disease. N Engl J Med 2012;367:2419-26.
  2. Lionetti E, Catassi C. New clues in celiac disease epidemiology, patho- genesis, clinical manifestations, and treatment. Int Rev Immunol 2011;30:219-31.
  3. Garsed K, Scott BB. Can oats be taken in a gluten-free diet? A systematic review. Scand J Gastroenterol 2007;42:171-8.
  4. Moulton ALC. The place of oats in the coeliac diet. Arch Dis Child 1959;34:51-5.
  5. Baker PG, Read AE. Oats and barley toxicity in coeliac patients. Postgrad Med J 1976;52:264-8.
  6. Janatuinen EK, Pikkarainen PH, Kemppainen TA, Kosma VM, Järvinen RM, Uusitupa MI, et al. A comparison of diets with and without oats in adults with celiac disease. N Engl J Med 1995;333:1033-7.
  7. Janatuinen EK, Kemppainen TA, Julkunen RJ, Kosma VM, Mäki M, Heikkinen M, et al. No harm from five year ingestion of oats in coeliac disease. Gut 2002;50:332-5.
  8. Srinivasan U, Leonard N, Jones E, Kasarda DD, Weir DG, O'Farrelly C, et al. Absence of oats toxicity in adult coeliac disease. BMJ 1996;313:1300- 1.
  9. Hardman CM, Garioch JJ, Leonard JN, Thomas HJ, Walker MM, Lortan JE, et al. Absence of toxicity of oats in patients with dermatitis herpetiformis. N Engl J Med 1997;337:1884-7.
  10. Reunala T, Collin P, Holm K, Pikkarainen P, Miettinen A, Vuolteenaho N, et al. Tolerance to oats in dermatitis herpetiformis. Gut 1998;43:490- 3.
  11. Kemppainen TA, Heikkinen MT, Ristikankare MK, Kosma VM, Sontag- Strohm TS, Brinck O, et al. Unkilned and large amounts of oats in the coeliac disease diet: a randomized, controlled study. Scand J Gastroenterol 2008;43:1094-101.
  12. Hollen E, Holmgren PK, Sundqvist T, Grodzinsky E, Hogberg L, Laurin P, et al. Coeliac children on a gluten-free diet with or without oats display equal anti-avenin antibody titers. Scand J Gastroenterol 2006;41:42- 7.
  13. Högberg L, Laurin P, Fälth-Magnusson K, Grant C, Grodzinsky E, Jansson G, et al. Oats to children with newly diagnosed coeliac disease: a randomised double blind study. Gut 2004;53:649-54.
  14. Storsrud S, Olsson M, Arvidsson Lenner R, Nilsson L, Nilsson O, Kilander A. Adult coeliac patients do tolerate large amounts of oats. Eur J Clin Nutr 2003;57:163-9.
  15. Hoffenberg EJ, Haas J, Drescher A, Barnhurst R, Osberg I, Bao F, et al. A trial of oats in children with newly diagnosed celiac disease. J Pediatr 2000;137:361-6.
  16. Koskinen O, Villanen M, Korponay-Szabo I, Lindfors K, Mäki M, Kaukinen K. Oats do not induce systemic or mucosal autoantibody response in children with coeliac disease. J Pediatr Gastroenterol Nutr 2009;48:559- 65.
  17. Holm K, Mäki M, Vuolteenaho N, Mustalahti K, Ashorn M, Ruuska T, et al. Oats in the treatment of childhood coeliac disease: a 2-year con- trolled trial and a long-term clinical follow-up study. Aliment Pharmacol Ther 2006;23:1463-72.
  18. Guttormsen V, Lovik A, Bye A, Bratlie J, Morkrid L, Lundin KE. No in- duction of anti-avenin IgA by oats in adult, diet-treated coeliac disease. Scand J Gastroenterol 2008;43:161-5.
  19. Sey MS, Parfitt J, Gregor J. Prospective study of clinical and histological safety of pure and uncontaminated canadian oats in the management of celiac disease. JPEN J Parenter Enteral Nutr 2011;35:459-64.
  20. Kaukinen K, Collin P, Huhtala H, Maki M. Long-term consumption of oats in adult celiac disease patients. Nutrients 2013;5:4380-9.
  21. Sjoberg V, Hollen E, Pietz G, Magnusson KE, Fälth-Magnusson K, Sundström M, et al. Noncontaminated dietary oats may hamper nor- malization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol 2014;5:e58.
  22. Tjellström B, Stenhammar L, Sundqvist T, Fälth-Magnusson K, Hollén E, Magnusson KE, et al. The effects of oats on the function of gut mi- croflora in children with coeliac disease. Aliment Pharmacol Ther 2014;39:1156-60.
  23. Tapsas D, Falth-Magnusson K, Hogberg L, Hammersjo JA, Hollen E. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long- term follow-up study. Nutr Res 2014;34:436-41.
  24. Picarelli A, Di Tola M, Sabbatella L, Gabrielli F, Di Cello T, Anania MC, et al. Immunologic evidence of no harmful effect of oats in celiac disease. Am J Clin Nutr 2001;74:137-40.
  25. Kilmartin C, Lynch S, Abuzakouk M, Wieser H, Feighery C. Avenin fails to induce a Th1 response in coeliac tissue following in vitro culture. Gut 2003;52:47-52.
  26. 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;106:665.
  27. Ellis HJ, Ciclitira PJ. Should coeliac sufferers be allowed their oats? Eur J Gastroenterol Hepatol 2008;20:492-3.
  28. Lundin KEA, Nilsen EM, Scott HG, Løberg EM, Gjøen A, Bratlie J, et al. Oats induced villous atrophy in coeliac disease. Gut 2003;52:1649-52.
  29. Peraaho M, Kaukinen K, Mustalahti K, Vuolteenaho N, Mäki M, Laippala P, et al. Effect of an oats-containing gluten-free diet on symptoms and quality of life in coeliac disease. A randomized study. Scand J Gastroenterol 2004;39:27-31.
  30. Arentz-Hansen H, Fleckenstein B, Molberg O, Scott H, Koning F, Jung G, et al. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med 2004;1:e1.
  31. Gatti S, Caporelli N, Galeazzi T, Francavilla R, Barbato M, Roggero P, et al. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study. Nutrients 2013;5:4653-64.
  32. Ballabio C, Uberti F, Manferdelli S, Vacca E, Boggini G, Redaelli R, et al. Molecular characterisation of 36 oat varieties and in vitro assessment of their suitability for coeliacs' diet. J Cereal Sci 2011;54:110-5.
  33. Svedlund J, Sjodin I, Dotevall G. GSRS: a clinical rating scale for gastro- intestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988;33:129-34.
  34. Generoso M, De Rosa M, De Rosa R, De Magistris L, Secondulfo M, Fiandra R, et al. Cellobiose and lactulose coupled with mannitol and de- termined using ion-exchange chromatography with pulsed amperometric detection, are reliable probes for investigation of intestinal permeabil- ity. J Chromatogr B Analyt Technol Biomed Life Sci 2003;783:349-57.
  35. Jones B, Kenward MG. Design and analysis of cross-over trials, Vol. 34. Monograph on statistics and applied probability. New York: Chapman and Hall; 1989.
  36. La Vieille S, Pulido OM, Abbott M, Koerner TB, Godefroy S. Celiac disease and gluten-free oats: a Canadian position based on a literature review. Can J Gastroenterol Hepatol 2016;2016:1870305.
  37. Vogelsang H, Schwarzenhofer M, Oberhuber G. Changes in gastrointes- tinal permeability in celiac disease. Dig Dis 1998;16:333-6.
  38. Duerksen DR, Wilhelm-Boyles C, Parry DM. Intestinal permeability in long-term follow-up of patients with celiac disease on a gluten-free diet. Dig Dis Sci 2005;50:85-90.
  39. Vilela EG, Ferrari ML, de Gama Torres HO, Martins FP, Goulart EM, Lima AS, et al. Intestinal permeability and antigliadin antibody test for moni- toring adult patients with celiac disease. Dig Dis Sci 2007;52:1304-9.
  40. Sadiq Butt M, Tahir-Nadeem M, Khan MK, Shabir R, Butt MS. Oat: unique among the cereals. Eur J Nutr 2008;47:68-79.

Cited by

Sorted by citations

Authors
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.
Affiliations
  • Marche Polytechnic University (IT)
  • University of Bari Aldo Moro (IT)
  • Sapienza University of Rome (IT)
  • University of Milan (IT)
  • University of Salerno (IT)
  • University of Catania (IT)
  • Ospedale di Bolzano (IT)
  • Ospedale Buccheri la Ferla Fatebenefratelli (IT)
Corresponding author
Lionetti, Elena
ORCID
Venue
The Journal of Pediatrics
Publisher
Elsevier BV
Published
2018-03
Volume
194
Pages
116-122.e2
ISSN
0022-3476 (ISSN-L)
DOI
10.1016/j.jpeds.2017.10.062
OpenAlex
W2790183617
Cited by
49
References
0
Citations by year
2026: 2 · 2025: 4 · 2024: 7 · 2023: 8 · 2022: 4 · 2021: 9 · 2020: 7 · 2019: 4 · 2018: 4
FWCI
5.71
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Journal of Pediatrics (publishedVersion)
  • PubMed (publishedVersion)
  • Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion, cc-by-nc-nd)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
  • Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
  • CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion, other-oa)
Funders
Heinz Italia S.p.A, Latina, Italy
Topics
  • Health Sciences › Medicine › Gastroenterology › Celiac Disease Research and Management
  • Health Sciences › Medicine › Surgery › Eosinophilic Esophagitis
  • Health Sciences › Nursing › Nutrition and Dietetics › Food composition and properties
Keywords
celiac disease, oat, gluten-free diet, children, dietary safety, intestinal permeability, gastrointestinal symptoms, body mass index, non-inferiority, avenin
MeSH terms
Celiac Disease, Child, Double-Blind Method, Female, Humans, Intestinal Mucosa, Male, Avena, Cross-Over Studies, Diet, Gluten-Free

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review