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.
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).
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).
Parallel
Colipral®
Dietary supplementColipral® is a probiotic food supplement in gastro-resistant capsules containing the probiotic strain Escherichia coli 5C (ECP24®). Participants will receive one capsule orally once daily, in the morning or evening, for 12 weeks.
Placebo
Other interventionMatching placebo identical in shape, color, and packaging to Colipral®, administered orally as one capsule daily in the morning or evening for 12 weeks.
Proportion of Participants With at Least One Episode of Symptomatic Cystitis
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.
Time to First Recurrence
Time from randomization to the first episode of symptomatic cystitis confirmed by urine culture.
Number of Total Cystitis Episodes
Total number of symptomatic cystitis episodes during the follow-up period.
Antibiotic Consumption
Number of antibiotic cycles and total days of antibiotic therapy during follow-up.
Urinary Pain
Urinary pain assessed using the Visual Analogue Scale (VAS).
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Liaquat University of Medical & Health Sciences
Lead sponsor
Ospedale degli Infermi di Biella
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
