A Phase 2 interventional study of Triticum monococcum in Celiac Disease, sponsored by Università degli Studi di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-08-19.
Sponsored by Università degli Studi di Brescia · Phase 2, Interventional, and Treatment
Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated.
The aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Università degli Studi di Brescia is the lead sponsor of 46 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
60 days of daily administration of 100 grams of water biscuits of Triticum monococcum
Dietary Supplement: Triticum monococcum
Histologic: 4 duodenal biopsies obtained and classified according to Marsh
After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist
Time frame: Baseline, Day 60
Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline, Day 30, Day 60
Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial
Time frame: Baseline, Day 30, Day 60
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Università degli Studi di Brescia