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Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Triticum monococcum
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease, Gluten, Gluten free diet, Triticum monococcum

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AO Spedali Civili of Brescia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triticum monococcum

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)

Full Information

First Posted
August 18, 2014
Last Updated
August 18, 2014
Sponsor
Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT02220166
Brief Title
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac Disease, Gluten, Gluten free diet, Triticum monococcum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triticum monococcum
Arm Type
Experimental
Arm Description
60 days of daily administration of 100 grams of water biscuits of Triticum monococcum
Intervention Type
Dietary Supplement
Intervention Name(s)
Triticum monococcum
Primary Outcome Measure Information:
Title
Histologic: 4 duodenal biopsies obtained and classified according to Marsh
Description
After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist
Time Frame
Baseline, Day 60
Secondary Outcome Measure Information:
Title
Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame
Baseline, Day 30, Day 60
Other Pre-specified Outcome Measures:
Title
Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial
Time Frame
Baseline, Day 30, Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Lanzini, MD, PhD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbara Zanini, MD, PhD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
AO Spedali Civili of Brescia
City
Brescia
ZIP/Postal Code
I-25123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23706063
Citation
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.
Results Reference
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Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

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