Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

August 18, 2014 updated by: Alberto Lanzini, MD PhD, Università degli Studi di Brescia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, I-25123
        • AO Spedali Civili of Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Triticum monococcum
60 days of daily administration of 100 grams of water biscuits of Triticum monococcum
Dietary supplement: Triticum monococcum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, Day 30, Day 60
Baseline, Day 30, Day 60

Other Outcome Measures

Outcome Measure
Time Frame
Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial
Time Frame: Baseline, Day 30, Day 60
Baseline, Day 30, Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Study Chair: Alberto Lanzini, MD, PhD, Università degli Studi di Brescia
  • Principal Investigator: Barbara Zanini, MD, PhD, Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (ESTIMATE)

August 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE-GA2-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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