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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triticum monococcum | Experimental | 60 days of daily administration of 100 grams of water biscuits of Triticum monococcum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triticum monococcum | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS) | Baseline, Day 30, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial | Baseline, Day 30, Day 60 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Lanzini, MD, PhD | Università degli Studi di Brescia | Study Chair |
| Barbara Zanini, MD, PhD | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO Spedali Civili of Brescia | Brescia | I-25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23706063 | Background | Zanini B, Petroboni B, Not T, Di Toro N, Villanacci V, Lanzarotto F, Pogna N, Ricci C, Lanzini A. 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. BMC Gastroenterol. 2013 May 24;13:92. doi: 10.1186/1471-230X-13-92. |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |