Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) for Prevention of Recurrent Cystitis in… (NCT07676604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) for Prevention of Recurrent Cystitis in Menopausal Women
134 participantsStarted 2026-07-06
Plain-language summary
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.
Who can participate
Age range
55 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants With at Least One Episode of Symptomatic Cystitis
Timeframe: 24 weeks
Trial details
NCT IDNCT07676604
SponsorLiaquat University of Medical & Health Sciences