The DOI matches its Crossref record.
Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease
Open accessAbstract
Background: Cereals of baking quality with absent or reduced toxicity are actively sought as alternative therapy to a gluten-free diet (GFD) for patients with coeliac disease (CD). Triticum monococcum, an ancient wheat, is a potential candidate having no toxicity in in-vitro and ex-vivo studies. The aim of our study was to investigate on the safety of administration of a single dose of gluten of Tm in patients with CD on GFD. Methods: We performed a single blind, cross-over study involving 12 CD patients who had been on a GFD for at least 12 months, challenged on day 0, 14 and 28 with a single fixed dose of 2.5 grams of the following (random order): Tm, rice (as reference atoxic protein) and Amygluten (as reference toxic protein) dispersed in a gluten-free pudding. The primary end-point of the study was the change in intestinal permeability, as assessed by changes in the urinary lactulose/rhamnose ratio (L/R ratio) measured by High Pressure Liquid Chromatography. We also assessed the occurrence of adverse gastrointestinal events, graded for intensity and duration according to the WHO scale. Variables were expressed as mean ± SD; paired t-test and χ 2 test were used as appropriate. Results: The urinary L/R ratio did not change significantly upon challenge with the 3 cereals, and was 0.055 ± 0.026 for Tm Vs 0.058 ± 0.035 for rice (p = 0.6736) and Vs 0.063 ± 0.054 with Amygluten (p = 0.6071). Adverse gastrointestinal events were 8 for Tm, Vs 11 for rice (p = 0.6321) and Vs 31 for Amygluten p = 0.0016), and, in all cases events were graded as “mild” or “moderate” with TM and rice, and as “severe” or “disabling” in 4 cases during Amygluten. Conclusions: No definite conclusion can be drawn on the safety of Tm, based on no change in urinary L/R because even Amygluten, a toxic wheat protein, did not cause a significant change in urinary L/R indicating low sensitivity of this methodology in studies on acute toxicity. Tm was, however, well tolerated by all patients providing the rationale for further investigation on the safety of this cereal for CD patients. Trial registration: EudraCT-AIFA n2008-000697-20
Overview
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.
Integrity signals
Registry
Cites
Statistics
Verification
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.
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?
Triticum monococcum was suggested to be safe for coeliac patients from a single-blind crossover study, but it was demonstrated to be toxic for patients with CD and should not be included in a GFD.
“One ancient isoform of wheat called Triticum monococcum was suggested to be safe for coeliac patients, from a one single-blind crossover study (11), however, it was demonstrated to be toxic for patients with CD and should not be included in a GFD (12,13).”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
No references could be resolved yet.
Research works printed but not linked: 19
- Fasano A, Catassi C: Clinical practice. Celiac disease. N Engl J Med. 2012, 367: 2419-2426. 10.1056/NEJMcp1113994. · DOI
- Whitaker JK, West J, Holmes GK, Logan RF: Patient perceptions of the burden of coeliac disease and its treatment in the UK. Aliment Pharmacol Ther. 2009, 29: 1131-1136. 10.1111/j.1365-2036.2009.03983.x. · DOI
- Lee AR, Ng DL, Diamond B, Ciaccio EJ, Green PH: Living with coeliac disease: survey results from the U.S.A. J Hum Nutr Diet. 2012, 25: 233-238. 10.1111/j.1365-277X.2012.01236.x. · DOI
- Rashtak S, Murray JA: Review article: coeliac disease, new approaches to therapy. Aliment Pharmacol Ther. 2012, 35: 768-781. 10.1111/j.1365-2036.2012.05013.x. · DOI
- Molberg O, Uhlen AK, Jensen T, Flaete NS, Fleckenstein B, Arentz-Hansen H, Raki M, Lundin KE, Sollid LM: Mapping of gluten T-cell epitopes in the bread wheat ancestors: implications for celiac disease. Gastroenterology. 2005, 128: 393-401. 10.1053/j.gastro.2004.11.003. · DOI
- Spaenij-Dekking L, Kooy-Winkelaar Y, van VP, Drijfhout JW, Jonker H, van SL, Smulders MJ, Bosch D, Gilissen LJ, Koning F: Natural variation in toxicity of wheat: potential for selection of nontoxic varieties for celiac disease patients. Gastroenterology. 2005, 129: 797-806. 10.1053/j.gastro.2005.06.017. · DOI
- De Vincenzi M, Vincentini O, Di NG, Boirivant M, Gazza L, Pogna N: Two prolamin peptides from durum wheat preclude celiac disease-specific T cell activation by gluten proteins. Eur J Nutr. 2010, 49: 251-255. 10.1007/s00394-009-0080-4. · DOI
- De Vincenzi M, Luchetti R, Giovannini C, Pogna NE, Saponaro C, Galterio G, Gasbarrini G: In vitro toxicity testing of alcohol-soluble proteins from diploid wheat Triticum monococcum in celiac disease. J Biochem Toxicol. 1996, 11: 313-318. 10.1002/(SICI)1522-7146(1996)11:6<313::AID-JBT7>3.0.CO;2-N. · DOI · Paper page
- De Vincenzi M, Stammati A, Luchetti R, Silano M, Gasbarrini G, Silano V: Structural specificities and significance for coeliac disease of wheat gliadin peptides able to agglutinate or to prevent agglutination of K562(S) cells. Toxicology. 1998, 127: 97-106. 10.1016/S0300-483X(98)00034-1. · DOI
- De Vincenzi M, Dessi MR, Giovannini C, Maialetti F, Mancini E: Agglutinating activity of wheat gliadin peptide fractions in celiac-disease. Toxicology. 1995, 96: 29-35. 10.1016/0300-483X(94)02912-E. · DOI
- Pizzuti D, Buda A, D’Odorico A, D’Inca R, Chiarelli S, Curioni A, Martines D: Lack of intestinal mucosal toxicity of Triticum monococcum in celiac disease patients. Scand J Gastroenterol. 2006, 41: 1305-1311. 10.1080/00365520600699983. · DOI
- Gianfrani C, Maglio M, Rotondi AV, Camarca A, Vocca I, Iaquinto G, Giardullo N, Pogna N, Troncone R, Auricchio S, Mazzarella G: Immunogenicity of monococcum wheat in celiac patients. Am J Clin Nutr. 2012, 96: 1339-1345. 10.3945/ajcn.112.040485. · DOI
- Greco L, D’Adamo G, Truscelli A, Parrilli G, Mayer M, Budillon G: Intestinal permeability after single dose gluten challenge in coeliac disease. Arch Dis Child. 1991, 66: 870-872. 10.1136/adc.66.7.870. · DOI
- Zanini B, Lanzarotto F, Mora A, Bertolazzi S, Turini D, Cesana B, Donato F, Ricci C, Lonati F, Vassallo F, Scarcella C, Lanzini A: Five year time course of celiac disease serology during gluten free diet: results of a community based “CD-Watch” program. Dig Liver Dis. 2010, 42: 865-870. 10.1016/j.dld.2010.05.009. · DOI
- Edwards IR, Biriell C: Harmonisation in pharmacovigilance. Drug Saf. 1994, 10: 93-102. 10.2165/00002018-199410020-00001. · DOI
- Paterson BM, Lammers KM, Arrieta MC, Fasano A, Meddings JB: The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study. Aliment Pharmacol Ther. 2007, 26: 757-766. 10.1111/j.1365-2036.2007.03413.x. · DOI
- Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA: A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol. 2012, 107: 1554-1562. 10.1038/ajg.2012.211. · DOI
- Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN: Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013, 37: 252-262. 10.1111/apt.12147. · DOI
- Katouzian F, Sblattero D, Not T, Tommasini A, Giusto E, Meiacco D, Stebel M, Marzari R, Fasano A, Ventura A: Dual sugar gut-permeability testing on blood drop in animal models. Clin Chim Acta. 2005, 352: 191-197. 10.1016/j.cccn.2004.09.023. · DOI
Cited by
Sorted by citations
Luque, V., Crespo‐Escobar, P., Hård af Segerstad, E. M., Koltai, T., Norsa, L., Roman, E., Vreugdenhil, A., Fueyo‐Díaz, R., & Ribes‐Koninckx, C. (2024) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1002/jpn3.12079 · Cited by 44
Metadata
- Authors
- Zanini, B., Petroboni, B., Not, T., Di Toro, N., Villanacci, V., Lanzarotto, F., Pogna, N., Ricci, C., & Lanzini, A.
- Affiliations
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- University of Trieste (IT)
- Corresponding author
- Lanzini, Alberto
- Venue
- BMC Gastroenterology
- Published
- 2013-05-24
- Volume
- 13
- Issue
- 1
- Pages
- 92-92
- ISSN
- 1471-230X (ISSN-L)
- PMC
- PMC3664588
- OpenAlex
- W2102120069
- Cited by
- 26
- References
- 0
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 5 · 2020: 4 · 2019: 4 · 2018: 3 · 2017: 3 · 2014: 1
- FWCI
- 0.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Gastroenterology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Celiac Disease Research and Management
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Wheat and Barley Genetics and Pathology
- Health Sciences › Nursing › Nutrition and Dietetics › Food composition and properties
- Keywords
- Triticum monococcum, emmer wheat, celiac disease, gluten-free diet, gluten challenge, intestinal permeability, lactulose/rhamnose ratio, rice, food safety, acute toxicity
- MeSH terms
- Celiac Disease, Edible Grain, Glutens, Humans, Intestinal Absorption, Lactulose, Plant Extracts, Rhamnose, Oryza, Triticum, Single-Blind Method, 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
