Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention and Treatment of Recurrent Urinary Tract Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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This randomized, open-label, controlled clinical trial evaluates the efficacy and safety of Lactobacillus crispatus M247 (CRISPACT®) in preventing recurrent urinary tract infections (rUTIs) in women. The study will enroll 130 adult female participants with a history of recurrent UTIs, defined as ≥3 episodes in the past year or ≥2 episodes in the past six months. Participants will be randomized into two groups: the Probiotic Group, receiving iNatal-duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) for 30 days, plus CRISPACT® (Lactobacillus crispatus M247) for 90 days; and the Control Group, receiving iNatal-duo® alone for 30 days without additional probiotic supplementation. The primary outcome is a reduction in the frequency and severity of rUTIs over 12 months, while secondary outcomes include symptom improvement, impact on quality of life, and safety assessments.

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Detailed Description

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Recurrent urinary tract infections (rUTIs) represent a significant public health issue, disproportionately affecting women with hormonal fluctuations, sexual activity-related risks, or previous antibiotic use. Standard treatment involves antibiotic therapy, which, while effective, contributes to antimicrobial resistance, gut microbiota imbalances, and increased recurrence risk. Probiotics, particularly Lactobacillus crispatus, have been shown to restore vaginal microbiota balance, prevent uropathogen overgrowth, and reduce the likelihood of rUTIs. This study aims to assess whether CRISPACT® (Lactobacillus crispatus M247), administered orally and vaginally, provides superior protection against rUTIs compared to standard care with iNatal-duo® alone.

The study will follow a randomized, controlled design with 130 participants divided into two arms. The Probiotic Group will receive iNatal-duo® for 30 days, combined with CRISPACT® (Lactobacillus crispatus M247) for 90 days, while the Control Group will receive iNatal-duo® alone for 30 days without additional probiotic supplementation. The primary objective is to evaluate the reduction in UTI recurrence over 12 months, measured through clinical diagnoses and patient-reported data. Secondary objectives include evaluating symptom relief, patient-reported quality of life improvements (EQ-5D, King's Health Questionnaire), and the safety and tolerability of probiotic therapy. The study seeks to provide scientific evidence for integrating probiotics into rUTI prevention strategies, reducing antibiotic dependence, and improving women's urogenital health.

Conditions

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Recurrent Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled, open-label study assessing the efficacy of Lactobacillus crispatus M247 (CRISPACT®) in preventing recurrent urinary tract infections (rUTIs) in women with a history of recurrent UTIs. Participants will be assigned to either the Probiotic Group, receiving CRISPACT® plus iNatal-duo®, or the Control Group, receiving iNatal-duo® alone. The primary outcome is the reduction in UTI recurrence over 12 months.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRISPACT® Group

Participants in this group will receive iNatal-duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) 1 sachet per day orally for 30 days, along with CRISPACT® (Lactobacillus crispatus M247) administered both orally and vaginally for 90 days. The intervention aims to assess whether probiotic therapy reduces the frequency and severity of recurrent urinary tract infections (rUTIs) over 12 months compared to standard treatment.

Group Type EXPERIMENTAL