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

NCT07676604 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-07-06

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Ospedale degli Infermi di Biella

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2027-07-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676604 on ClinicalTrials.gov