Recurrent Cystitis
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTColipral®
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.
OTHERPlacebo
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
Liaquat University of Medical & Health Sciences
Ospedale degli Infermi di Biella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With at Least One Episode of Symptomatic Cystitis | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Recurrence | 24 weeks | Time from randomization to the first episode of symptomatic cystitis confirmed by urine culture. |
| Number of Total Cystitis Episodes | 24 weeks | Total number of symptomatic cystitis episodes during the follow-up period. |
| Antibiotic Consumption | 24 weeks | Number of antibiotic cycles and total days of antibiotic therapy during follow-up. |
| Urinary Pain | 24 weeks | Urinary pain assessed using the Visual Analogue Scale (VAS). |
| Quality of Life and Symptom Severity | 24 weeks | Quality of life and symptom severity assessed using the UTI-SIQ-8 questionnaire. |
Contacts
CONTACTAlessandro Messina, MD
Outcome results
None listed