NL-OMON31647已完成不适用
Study On The Effectiveness Of Oral Administration Of Prolyl Endoprotease For Gluten Detoxification As A Means To Treat Coeliac Disease - AN-PEP supportive treatment in coeliac disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Confirmed diagnosis of coeliac disease (Marsh III B/C)
- •* Detectable coeliac disease specific antibodies (EMA, tTGA) at time of diagnosis.
- •* A strict gluten free diet for at least 1 year and normalised villous architecture (Marsh 0/I);
- •* Male and female, 18-70 years old;
- •* No detectable anti-endomysium and low anti-tissue transglutaminase (< 4 U/ml) prior to the start of the study;
- •* Patient is willing to undergo all protocol related assessments and visits (including up to 3 separate oesophago-gastro-duodenoscopies with multiple biopsies taken each time) from the duodenum descendents;
- •* Patient has read the information provided on the study and given written consent;
- •* Female participants at fertile age must use adequate contraception.
排除标准
- •* Use of any immunoregulatory drug within the last 6 months;
- •* Use of any anticoagulant drug;
- •* Clinically suspected bleeding tendency;
- •* Pregnancy or breast feeding;
- •* Presence of any concurrent active infection;
- •* IgA deficiency.
研究者
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