Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

NCT02220166 | Completed Phase 2

• 1 other identifier: GE-GA2-2010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Celiac Disease; Gluten; Gluten free diet; Triticum monococcum

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline, Day 30, Day 60

Other Outcomes (1)

• Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial

  Baseline, Day 30, Day 60

Study Arms (1)

Triticum monococcum

EXPERIMENTAL

60 days of daily administration of 100 grams of water biscuits of Triticum monococcum

Dietary Supplement: Triticum monococcum

Interventions

Triticum monococcum DIETARY_SUPPLEMENT

Triticum monococcum

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

AO Spedali Civili of Brescia

Brescia, I-25123, Italy

Location

Related 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.

  PMID: 23706063 BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alberto Lanzini, MD, PhD

  Università degli Studi di Brescia

  STUDY CHAIR

• Barbara Zanini, MD, PhD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 19, 2014
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

IT (1)