CTRI/2016/11/007513招募中未知
A randomized, double-blind, parallel group, placebo-controlled, multicentre pilot study of Bio-Kult Pro-Cyan probiotic in recurrenturinary tract infections (UTI) in adult females.
Probiotics International Ltd0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
入选标准
- •1. Female subjects aged >=18 and <= 55 years who are willing to provide written informed consent to participate in the study
- •2. Subjects who have had at least 2 or more episodes of uncomplicated acute UTIs in last six months or three or more episodes of uncomplicated acute UTIs in last 12 months
- •3. Willing and able to comply with the requirements of the protocol and available for the planned duration of the study
- •4. Willing to avoid all supplements and foods that contain cranberries for the duration of the study
- •5. Willing to avoid all other probiotics supplements for the duration of the study
- •6. Subject must be surgically sterile prior to participation in trial
- •Subjects who are of child bearing potential must be willing to use a suitable and effective contraceptive method for the study duration. Results of the pregnancy test done at screening must be negative and available prior to randomization visit.
排除标准
- •1. Subjects having active UTI
- •2. Subject is post-menopausal
- •3. Pregnant or breast-feeding women
- •4. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline
- •5. Women of childbearing potential who are unwilling to use acceptable contraceptive methods during the course of study. Acceptable methods of contraception include combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of
- •ovulation (oral, intravaginal, or transdermal); progesteroneonly hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intra-uterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence; or male condom in combination with either cap, diaphragm, or sponge with spermicide (double-barrier contraception)
- •6. Known history of Human Immunodeficiency Virus (HIV) infection
- •7. Participation in another clinical trial within the last one month prior to entry in this study
研究者
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