Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) for Prevention of Recurrent Cystitis in Menopausal Women

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Cystitis
• Intervention / Treatment: Dietary supplement: Colipral®; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Messina, MD; Phone Number: 011 56 16 111; Email: alessandro.messina@aslbi.piemonte.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Colipral®; Colipral® 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 Comparator: 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.	Other: Placebo; Matching placebo identical in shape, color, and packaging to Colipral®, administered orally as one capsule daily in the morning or evening for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Recurrence	Time from randomization to the first episode of symptomatic cystitis confirmed by urine culture.	24 weeks
Number of Total Cystitis Episodes	Total number of symptomatic cystitis episodes during the follow-up period.	24 weeks
Antibiotic Consumption	Number of antibiotic cycles and total days of antibiotic therapy during follow-up.	24 weeks
Urinary Pain	Urinary pain assessed using the Visual Analogue Scale (VAS).	24 weeks
Quality of Life and Symptom Severity	Quality of life and symptom severity assessed using the UTI-SIQ-8 questionnaire.	24 weeks

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: Ospedale degli Infermi di Biella

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis
• Other Study ID Numbers: 388/CE, 09.06.2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No