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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
AO Spedali Civili of Brescia
Brescia, Italy
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
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