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临床试验/EUCTR2019-002762-12-DK
EUCTR2019-002762-12-DK进行中(未招募)1 期

The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis

Zealand University Hospital0 个研究点目标入组 54 人开始时间: 2019年7月25日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
54

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

性别
All

入选标准

  • Suspected activity in MC, defined by Hjortswang criteria: 3 stools daily OR one watery (Bristol type 6or7) stools daily, as a mean over the last 6-7 days.
  • Proven microscopic colitis (collagenous, lymphocytic or incomplete) in biopsies from the last 6 years
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 29

排除标准

  • Age < 18 years
  • Intestinal resection other than appendectomy
  • cholecystectomy
  • Other chronic intestinal disease with diarrhoea
  • Use of other constipation agent than loperamide
  • Systemic treatment with steroid within 2 weeks of the start of treatment
  • Suspected or proven gastrointestinal infection
  • Allergy to budesonide
  • Lack of compliance or understanding of the trial
  • If taking statin or fibrate therapy: unwilling to pause medical treatment against hypercholesterolaemia

研究者

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