CTRI/2024/03/064088招募中3 期
A randomized double-blind, placebo-controlled, parallel multicenter phase III study to evaluate the effectiveness and safety of Probiotic blend of strains on the clinical and biological parameters of women with urinary tract infection - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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.Post-menopausal women >12 months since their last menstrual period. Menopause may be natural or induced due to surgical or medical intervention.
- •2.Have a history of recurrent UTIs, defined as = 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit (Visit 1), at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.
排除标准
- •Patients with history or significant presence of the following will be excluded from participation or enrollment in the study trial:
- •Immunosuppressed
- •Known allergies to investigational product or its excipients
- •Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening
- •Women who have needed changes to medical intervention or in-office procedures in the last 3 months
- •Women who wear a pessary
- •Women who use catheters regularly
- •Women with an obstruction or neurogenic bladder causing incomplete bladder emptying. Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within the previous 30 days.
- •Individuals that have a significant acute or chronic coexisting illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease, severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer.
- •Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
研究者
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