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Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02220166
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Information provided by (Responsible Party):
Alberto Lanzini, MD PhD, 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: Triticum monococcum Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Triticum monococcum
60 days of daily administration of 100 grams of water biscuits of Triticum monococcum
Dietary Supplement: Triticum monococcum

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Baseline, Day 30, Day 60 ]

Other Outcome Measures:
  1. Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial [ Time Frame: Baseline, Day 30, Day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02220166

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AO Spedali Civili of Brescia
Brescia, Italy, I-25123
Sponsors and Collaborators
Università degli Studi di Brescia
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Study Chair: Alberto Lanzini, MD, PhD Università degli Studi di Brescia
Principal Investigator: Barbara Zanini, MD, PhD Università degli Studi di Brescia
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Responsible Party: Alberto Lanzini, MD PhD, Associate Professor of Gastroenterology, Università degli Studi di Brescia Identifier: NCT02220166    
Other Study ID Numbers: GE-GA2-2010
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Alberto Lanzini, MD PhD, Università degli Studi di Brescia:
Celiac Disease
Gluten free diet
Triticum monococcum
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases