Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Phase 2

Completed

• Conditions: Celiac Disease
• Interventions: Dietary Supplement: Triticum monococcum

• Registration Number: NCT02220166
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Adult Celiac patients on Gluten Free Diet (GFD) for at least one year
• Strict adherence to GFD
• Negative Celiac related serology
• Normal duodenal Histology defined as Marsh Class 0-II
• Willing to participate and adhere to study protocol
• Sign of the informed consent

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triticum monococcum	Triticum monococcum	60 days of daily administration of 100 grams of water biscuits of Triticum monococcum

Primary Outcome Measures

Name	Time	Method
Histologic: 4 duodenal biopsies obtained and classified according to Marsh	Baseline, Day 60	After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist

Secondary Outcome Measures

Name	Time	Method
Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)	Baseline, Day 30, Day 60

Trial Locations

Locations (1)

AO Spedali Civili of Brescia; 🇮🇹 Brescia, Italy