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Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention and Treatment of Recurrent Urinary Tract Infections
Sponsor: Liaquat University of Medical & Health Sciences
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: Interventional Study on the Efficacy of Lactobacillus Crispatus M247 for Prevention and Treatment of Recurrent Urinary Tract Infections in Combination With Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 (URTI): A Randomized Controlled Pilot Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-03-05
Completion Date
2026-04-17
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Lactobacillus crispatus M247
CRISPACT® (Lactobacillus crispatus M247), PharmExtracta S.p.A
iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)
iNatal-Duo®, PharmExtracta S.p.A
Locations (1)
Medicine & Technological Innovation Dept. University of Insubria
Varese, Italy