Triticum monococcum in patients with celiac disease: a phase II open study on safety of prolonged daily administration

BACKGROUND AND AIMS: To assess safety of prolonged daily administration of Triticum monococcum (Tm) using clinical, serological and histological criteria. Tm is an ancient wheat suitable for production of palatable baked goods that contains gluten devoid of strongly immunostimulatory epitopes and potentially safe for celiac disease (CD) patients as suggested by in vitro and ex vivo studies. METHODS: Protocol involved 60-day administration of 100 g/day Tm water biscuits to CD patients in remission on gluten-free diet. Symptoms Gastrointestinal Symptom Rating Scale questionnaire (GSRS) and CD-related serology were assessed at time (T) 0, T30 and T60 days, and duodenal biopsy was obtained at T0 and T60. RESULTS: Eight patients (F/M: 6/2, median age 26) were enrolled. One patient was excluded at T0 because of positive serology, and two patients dropped out because of symptoms recurrence. In the five patients completing the study, there was no difference in GSRS score at T0 to T60. All patients had Marsh II lesion at T0, four had Marsh III and one had recurrence of dermatitis herpetiformis at T60. CD-related antibodies converted from negative to positive at T60 in three patients. CONCLUSIONS: Our study shows that Tm is toxic for CD patients as judged on histological and serological criteria, but it was well tolerated by the majority of patients, suggesting that Tm is not a safe cereal for celiacs, but that it may be of value for patients with gluten sensitivity or for prevention of CD.