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临床试验/jRCTs061180053
jRCTs061180053已完成不适用

A clinical study evaluating the effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection (A study evaluating the effectiveness of Lactobacillus vaginal suppositories in recurrent urinary tract infection)

未提供0 个研究点目标入组 50 人开始时间: 2014年2月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Prevention Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
20age old over 至 No limit(—)
性别
Female

入选标准

  • Acute simple cystitis
  • Acute exacerbation of chronic complicated cystitis occurring in patients using clean intermittent catheterization
  • Acute exacerbation of chronic complicated cystitis in neurogenic bladder and overactive bladder with residual urine volume of 50 mL or less
  • Other acute exacerbations of chronic complicated cystitis occurred in mild basic disease of the urinary tract
  • The episode of urinary tract infection in need of intervention corresponding to any one of the above 1) to 4) has been found twice or more in the recent 1 year and the female patients of below 1) to 3)
  • Patients who have already completed treatment with urinary tract infection antibiotics
  • Patients over 20 years old
  • Outpatient(Non-hospitalized patient)

排除标准

  • Patients requiring urological treatment such as urolithiasis, hydronephrosis, urinary tract tumors
  • Patient indwelling urethral catheter
  • Patients with severe underlying disease and complications such as poorly controlled diabetes, collagen disease, leukemia, advanced cancer, congestive heart failure, severe liver or renal dysfunction
  • Patients who had seen allergic hypersensitivity symptoms by ingestion of dairy products or lactobacillus products in the past
  • Patients who have sex partner, whose partner have had allergic hypersensitivity symptoms by ingestion of dairy products or lactobacillus products in the past
  • Patients who wish to have babies within one year and patients who are pregnant
  • Patients who were judged inappropriate as subjects of this study by doctors

结局指标

主要结局

-

Response rate of Lactobacillus vaginal supposite in 1 year during administration

次要结局

  • Response rate of Lactobacillus vaginal supposite(1 year after completion of administration)
  • Number of recurrence of urinary tract infection(1 year during administration and 1 year after completion of administration)
  • Changes in urine and vaginal separating bacteria
  • Adverse event

研究者

发起方
未提供

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