Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triticum monococcum

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

Group Type EXPERIMENTAL

Triticum monococcum

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Triticum monococcum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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