Trial reportBMC gastroenterology2013
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.
Trial report in BMC gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02220166 (Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Gastrointestinal and Extraintestinal Symptoms Among Subjects With Celiac Disease Undergoing a Dose-Specified Gluten Challenge: A Systematic Review and Meta-Analysis.The American journal of gastroenterology · 2026Pooled it
- Review on pediatric coeliac disease from a clinical perspective.European journal of pediatrics · 2022Review
- Potential tolerability of ancient grains in non-celiac wheat sensitivity patients: A preliminary evaluation.Frontiers in medicine · 2022Article
- Spanish Spelt Wheat: From an Endangered Genetic Resource to a Trendy Crop.Plants (Basel, Switzerland) · 2021Review
- New Insights into Non-Dietary Treatment in Celiac Disease: Emerging Therapeutic Options.Nutrients · 2021Review
- Ancient and Modern Cereals as Ingredients of the Gluten-Free Diet: Are They Safe Enough for Celiac Consumers?Foods (Basel, Switzerland) · 2021Review
- Differential Physiological Responses Elicited by Ancient and Heritage Wheat Cultivars Compared to Modern Ones.Nutrients · 2019Review
- Scouting for Naturally Low-Toxicity Wheat Genotypes by a Multidisciplinary Approach.Scientific reports · 2019Article
- The role of diet in the prevention and treatment of Inflammatory Bowel Diseases.Acta bio-medica : Atenei Parmensis · 2018Review
- "Eat as If You Could Save the Planet and Win!" Sustainability Integration into Nutrition for Exercise and Sport.Nutrients · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCereals 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.
methodsWe 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 χ² test were used as appropriate.
resultsThe 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.
conclusionsNo 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 registrationEudraCT-AIFA n2008-000697-20.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.