Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Celiac Disease Clinical Trial

Official title:

Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220166
• Other study ID #: GE-GA2-2010
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2014
• Last updated: August 18, 2014
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2014
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Triticum monococcum

Locations

Country	Name	City	State
Italy	AO Spedali Civili of Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial		Baseline, Day 30, Day 60	Yes
Primary	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	Yes
Secondary	Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)		Baseline, Day 30, Day 60	Yes