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Completed

NCT Number: NCT02220166

Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AO Spedali Civili of Brescia

Brescia, I-25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triticum monococcum

Dietary Supplement

Primary outcomes

  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 outcomes

  1. Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Baseline, Day 30, Day 60

Other outcomes

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

    Time frame: Baseline, Day 30, Day 60

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2014
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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