跳至主要内容
临床试验/NCT03259659
NCT03259659终止不适用

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
1
主要终点
symptoms characteristics in ulcerative colitis patients

研究概览

简要总结

  1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.
  2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. Presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No any systemic diseases;
  • no proctitis or proctosigmoiditis;
  • no history of gastrointestinal surgery;
  • no symptoms of diarrhea or fecal urgency during the past 2 weeks;
  • not taking any medications except contraceptives during the past 2 weeks;
  • age 18-65.

排除标准

  • 未提供

结局指标

主要结局

symptoms characteristics in ulcerative colitis patients

时间窗: 1 day

ulcerative colitis disease activity index will be assessed using the Mayo scoring system, which includes stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. The patient will get a score from 0 to 20, with higher score indicating more severe disease.

次要结局

  • autonomic profile characteristics in ulcerative colitis patients and healthy controls(1 day)
  • microbiota profile in ulcerative colitis patients and healthy controls(1 day)
  • inflammatory cytokine profile in ulcerative colitis patients and healthy controls(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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