Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Histologic: 4 duodenal biopsies obtained and classified according to Marsh
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
结局指标
主要结局
Histologic: 4 duodenal biopsies obtained and classified according to Marsh
时间窗: Baseline, Day 60
After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist
次要结局
- Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)(Baseline, Day 30, Day 60)
研究者
Alberto Lanzini, MD PhD
Associate Professor of Gastroenterology
Università degli Studi di Brescia