An interventional study of Colipral® and Placebo in Recurrent Cystitis, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting. Open to female participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Prevention
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.
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 134 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®
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
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.
Matching 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 frame: 24 weeks
Time to First Recurrence
Time from randomization to the first episode of symptomatic cystitis confirmed by urine culture.
Time frame: 24 weeks
Number of Total Cystitis Episodes
Total number of symptomatic cystitis episodes during the follow-up period.
Time frame: 24 weeks
Antibiotic Consumption
Number of antibiotic cycles and total days of antibiotic therapy during follow-up.
Time frame: 24 weeks
Urinary Pain
Urinary pain assessed using the Visual Analogue Scale (VAS).
Time frame: 24 weeks
Quality of Life and Symptom Severity
Quality of life and symptom severity assessed using the UTI-SIQ-8 questionnaire.
Time frame: 24 weeks
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences