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

NCT07676604 | Not Yet Recruiting DMC

• 1 other identifier: 388/CE, 09.06.2026
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Recurrent Cystitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Colipral®

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Interventions

Colipral® DIETARY_SUPPLEMENT

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.

Colipral®

Placebo OTHER

Matching placebo identical in shape, color, and packaging to Colipral®, administered orally as one capsule daily in the morning or evening for 12 weeks.

Placebo

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Ospedale degli Infermi di Biella: collaborator

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Alessandro Messina, MD

CONTACT

011 56 16 111; alessandro.messina@aslbi.piemonte.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants will be randomized in a 1:1 ratio to receive either Colipral® or matching placebo. The study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 24 weeks of follow-up.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07