Clinical trial NCT06857565: Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention and Treatment of Recurrent Urinary Tract Infections
Official title: Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Prevention and Treatment of Recurrent URinary Tract Infections in Association With Supplementation With Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 (URTI): A Controlled Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2025-03-04
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* History of recurrent urinary tract infections (rUTIs) with at least 3 episodes per year.
* No antibiotic treatment in the past 4 weeks before enrollment.
* Not currently pregnant or breastfeeding.
* Willing to provide vaginal and urine samples for microbiota analysis.
* Able to provide informed consent and comply with study procedures.

Exclusion Criteria:

* Current urinary tract infection (UTI) at the time of enrollment.
* Use of immunosuppressive therapy or presence of immunodeficiency disorders.
* Use of other probiotics within 4 weeks before enrollment.
* Known allergy or hypersensitivity to study products (Lactobacillus crispatus M247 or iNatal-duo®).
* History of pelvic radiation therapy or major gynecological surgery.
* Severe gastrointestinal conditions, including inflammatory bowel disease.

Primary outcomes:
measure: Change in Recurrent Urinary Tract Infections (rUTIs)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Vaginal Microbiota Composition
timeFrame: Baseline, 3 months, 12 months
measure: Change in Antibiotic Use for UTIs
timeFrame: 12 months
measure: Change in urinary discomfort
timeFrame: Baseline, 6 months, 12 months
measure: Change in pain severity
timeFrame: Baseline, 6 months, 12 months
measure: Change in overall well-being
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Medicine & Technological Innovation Dept. University of Insubria
Study officials:
References: