Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02220166

Enrollment

Registered

2014-08-19

Start date

2010-11-30

Completion date

2011-08-31

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease, Gluten, Gluten free diet, Triticum monococcum

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.

Interventions

DIETARY_SUPPLEMENTTriticum monococcum

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026