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

NCT06857565 | Completed DMC

• 1 other identifier: 0038288/22/07.12.2022
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Recurrent Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Cumulative number of symptomatic UTI recurrences per participant

  Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 12-month follow-up

  12 months

Secondary Outcomes (11)

• Change in urinary symptoms (King's Health Questionnaire)

  Baseline, 3 months

• Pelvic pain and urgency/frequency symptom burden at month 3

  3 months

• Change in health-related quality of life (EQ-5D)

  Baseline, 3 months

• Change in sexual function

  Baseline, 3 months

• Treatment adherence

  3 months

Study Arms (2)

CRISPACT® Group

EXPERIMENTAL

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 orally for 90 days. The intervention aims to assess whether probiotic therapy reduces the frequency of recurrent urinary tract infections (rUTIs) over a 12-month follow-up period compared with control treatment.

Dietary Supplement: Lactobacillus crispatus M247; Dietary Supplement: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)

Control Group

ACTIVE COMPARATOR

Participants in this group will receive iNatal-Duo® alone 1 sachet per day orally for 30 days without additional probiotic supplementation. This group will serve as a control to evaluate the comparative effectiveness of probiotic supplementation in preventing rUTI recurrence.

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

Interventions

Lactobacillus crispatus M247 DIETARY_SUPPLEMENT

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

CRISPACT® Group

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

iNatal-Duo®, PharmExtracta S.p.A

CRISPACT® Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since the study focuses on recurrent urinary tract infections, which are more prevalent in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women aged 18-65 years.
• History of recurrent urinary tract infections (rUTIs), defined as ≥3 episodes in the past year or ≥2 episodes in the past 6 months.
• Able to provide informed consent and comply with study procedures.

You may not qualify if:

• Age \<18 years.
• Ongoing complicated cystitis or uncomplicated pyelonephritis.
• History of urological abnormalities or kidney stones.
• Recent sexually transmitted infection or bacterial vaginosis, or history of recurrent bacterial vaginosis.
• Risk factors for sexually transmitted diseases.
• Ongoing pregnancy, planning pregnancy, or breastfeeding.
• Diagnosis of diabetes mellitus.
• Diagnosis of HIV infection or other immunocompromised states.
• Recent history of drug or alcohol abuse.
• Persistent symptoms and/or pyuria after acute UTI treatment.
• Uterine, cervical, vaginal, or urethral cancer.
• Urethral diverticulum.
• Tuberculous, radiation-induced, cyclophosphamide-induced, or chemical cystitis.
• Benign or malignant bladder tumors.
• Recent diagnosis of vaginitis.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

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

Rome, Rome (RM), 00168, Italy

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: 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 are assigned to either the Probiotic Group, receiving CRISPACT® plus iNatal Duo®, or the Control Group, receiving iNatal Duo® alone. The primary outcome is the number of rUTI episodes during the 12-month follow-up period.

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 4, 2025
• Study Start: March 5, 2025
• Primary Completion: April 11, 2026
• Study Completion: April 11, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)