Study to Evaluate the Efficacy and Safety of Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) in the Prevention of Recurrent Cystitis in Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 主要终点
- Proportion of Participants With at Least One Episode of Symptomatic Cystitis
研究概览
简要总结
Recurrent cystitis is a common condition in menopausal women and is associated with impaired quality of life and increased antibiotic use. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Colipral® in preventing recurrent cystitis in menopausal women. Participants will be randomized to receive either Colipral® (probiotic strain Escherichia coli 5C (ECP24®)))or placebo for 12 weeks and will be followed for a total of 24 weeks. The study will assess the occurrence of symptomatic cystitis recurrences confirmed by urine culture, as well as symptoms, quality of life, urinary pain, and antibiotic consumption.
详细描述
Recurrent cystitis, defined as two or more episodes within 6 months or three or more episodes within 12 months, is particularly frequent in menopausal women because of age-related changes in estrogen levels, the urogenital epithelium, and the microbiota. The gastrointestinal tract is considered an important reservoir of uropathogenic bacteria, and intestinal dysbiosis may contribute to recurrent urinary tract infections.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate whether Colipral® (probiotic strain Escherichia coli 5C (ECP24®)) reduces the proportion of menopausal women experiencing recurrent symptomatic cystitis compared with placebo during a 24-week follow-up period. Recurrence is defined as the appearance of urinary symptoms compatible with the need for therapy and confirmed by urine culture.
A total of 134 menopausal women with recurrent cystitis will be enrolled and randomized in a 1:1 ratio to receive either Colipral® or placebo. Participants in the active treatment group will receive one capsule daily for 12 weeks, while participants in the control group will receive an identical placebo for the same duration. The follow-up period will continue beyond treatment discontinuation to evaluate the persistence of the preventive effect.
Secondary objectives include evaluation of the number of cystitis episodes, time to first recurrence, antibiotic consumption, urinary pain assessed by the Visual Analogue Scale (VAS), symptom severity, and quality of life assessed using the UTI-SIQ-8 questionnaire.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be conducted in a double-blind manner. Participants, care providers, investigators, and outcome assessors will remain blinded to treatment allocation. Active treatment and placebo will be indistinguishable in appearance and packaging. Unblinding will only be permitted in emergency situations.
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal female patients.
- •Age between 55 and 70 years.
- •Diagnosis of recurrent cystitis: ≥2 episodes in 6 months or ≥3 episodes in 12 months, with at least 1 documented episode from urine culture in the last 12 months (if available).
排除标准
- •Complicated urinary tract infections (UTIs) or major complicating factors, including relevant anatomical abnormalities, catheterization, active calculosis, or significant immunosuppression.
- •Hormone replacement therapy (HRT) that has been ongoing or discontinued for less than 6 months.
- •Pyelonephritis within the past 6 months.
- •Ongoing continuous antibiotic prophylactic therapy (or inability to suspend it).
- •Chronic inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
- •Allergy to the probiotic or its excipients.
研究组 & 干预措施
Colipral®
Participants will receive Colipral® at a dose of 1 capsule per day, administered in the morning or evening, for 12 weeks. The study will evaluate the efficacy and safety of Colipral® in the prevention of recurrent cystitis in menopausal women.
干预措施: Colipral® (Dietary Supplement)
Placebo
Participants will receive placebo capsules identical in shape, color, and packaging to Colipral®, administered as 1 capsule per day in the morning or evening for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of Participants With at Least One Episode of Symptomatic Cystitis
时间窗: 24 weeks
Proportion of participants with at least one episode of symptomatic cystitis during the 24-week follow-up period. Each episode must meet clinical criteria and have microbiological confirmation by urine culture.
次要结局
- Time to First Recurrence(24 weeks)
- Number of Total Cystitis Episodes(24 weeks)
- Antibiotic Consumption(24 weeks)
- Urinary Pain(24 weeks)
- Quality of Life and Symptom Severity(24 weeks)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences