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

Recurrent cystitis, defined as two or more episodes within 6 months or three or moreepisodes within 12 months, is particularly frequent in menopausal women because ofage‐related changes in estrogen levels, the urogenital epithelium, and the microbiota.The gastrointestinal tract is considered an important reservoir of uropathogenicbacteria, and intestinal dysbiosis may contribute to recurrent urinary tract infections.This study is a randomized, double‐blind, placebo‐controlled, parallel‐group clinicaltrial designed to evaluate whether Colipral® (probiotic strain Escherichia coli 5C(ECP24®)) reduces the proportion of menopausal women experiencing recurrent symptomaticcystitis compared with placebo during a 24‐week follow‐up period. Recurrence is definedas the appearance of urinary symptoms compatible with the need for therapy and confirmedby urine culture.A total of 134 menopausal women with recurrent cystitis will be enrolled and randomizedin a 1:1 ratio to receive either Colipral® or placebo. Participants in the activetreatment group will receive one capsule daily for 12 weeks, while participants in thecontrol group will receive an identical placebo for the same duration. The follow‐upperiod will continue beyond treatment discontinuation to evaluate the persistence of thepreventive effect.Secondary objectives include evaluation of the number of cystitis episodes, time to firstrecurrence, antibiotic consumption, urinary pain assessed by the Visual Analogue Scale(VAS), symptom severity, and quality of life assessed using the UTI‐SIQ‐8 questionnaire.