NCT03042273已完成2 期
A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of High Strength Cranberry (Pacran®) in Women With Recurrent Urinary Tract Infections (Cystitis)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Incidence of UTI
研究概览
简要总结
This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18-65 years, inclusive
- •A history of recurrent urinary tract infection defined as ≥3 UTIs in the last year OR at least 2 UTIs occurring in the last 6 months. Each infection requires confirmation by a health professional
- •Willing to answer questionnaires and comply with the study requirements
- •Ability to swallow capsules
- •Provided Written Informed Consent
- •BMI >17.5kg m2 and <35kg m2
排除标准
- •Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1
- •A history of >5 UTIs in the last 6 months (confirmed by self-report or health professional)
- •Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1
- •Use of any antibacterial products, that in the opinion of the Medical Investigator may interfere with the study outcomes, within 28 days of Day 1
- •Regular use of Vaccinium containing products (e.g. all forms of blueberries, cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or supplements) within 28 days of Day 1 at the discretion of the Medical Investigator
- •Presence of an intermittent or indwelling urinary catheter
- •Anatomical abnormalities of the urinary tract
- •History of or known clinically significant renal or urological disease(self-reported)
- •Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or breastfeeding
- •Women of Childbearing potential not willing to use adequate and effective methods of contraception throughout the study
- •Women of child bearing potential that have not been using effective methods of contraception for 14 days prior to Day 1
- •History of or known clinically significant cardiac disease
- •History of or known clinically significant liver disease
- •History of or known clinically significant gastrointestinal disease
- •History of or known metabolic disorder or diabetes
- •History or presence of alcohol or illicit drug abuse,any surgical history, clinical condition or organ dysfunction that in the opinion of the Medical Investigator may affect the participant's ability to participate in the study or the study results
- •Currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product
- •Immunocompromised participants or participants receiving immunosuppressive medication
- •History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
- •Currently taking warfarin or has received Warfarin within 28 days of Day 1
- •Received an investigational drug within 28 days of Day 1
结局指标
主要结局
Incidence of UTI
时间窗: 6 months
cultured confirmed UTIs at a level of \>108cfu/L (105cfu/mL)
次要结局
未报告次要终点
研究者
研究点 (8)
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