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COMPLETED
NCT06857565
NA

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

Sponsor: Liaquat University of Medical & Health Sciences

View on ClinicalTrials.gov

Summary

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 enrolls 84 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 are 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) administered orally for 90 days; and the Control Group, receiving iNatal Duo® alone for 30 days without additional probiotic supplementation. The primary outcome is the reduction in the frequency of rUTIs over 12 months, while secondary outcomes include symptom improvement, quality of life, and safety assessments.

Official title: Oral Lactobacillus Crispatus M247 as an Add-on to Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 for the Prevention of Recurrent Urinary Tract Infections in Women: A Prospective Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-03-05

Completion Date

2026-04-11

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Lactobacillus crispatus M247

CRISPACT® (Lactobacillus crispatus M247), PharmExtracta S.p.A

DIETARY_SUPPLEMENT

iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)

iNatal-Duo®, PharmExtracta S.p.A

Locations (1)

Complex Operating Unit of Surgical Gynecology and Pelvic Floor Reconstructive Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Rome (RM), Italy