Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Università degli Studi di Brescia

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Dietary Supplement: Triticum monococcum

Study type: Interventional

Funder types: Other

Identifiers

NCT02220166

GE-GA2-2010

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Triticum monococcum

Experimental group

Description:

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

Treatment:

Dietary Supplement: Triticum monococcum