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

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.

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.