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

Liaquat University of Medical & Health Sciences

Status: Active, not recruiting

Conditions: Recurrent Urinary Tract Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06857565

0038288/22/07.12.2022

Details and patient eligibility

About

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.

Full description

Recurrent urinary tract infections (rUTIs) represent a significant public health issue, disproportionately affecting women with hormonal fluctuations, sexual activity-related risks, or prior antibiotic exposure. Standard treatment relies on antibiotic therapy, which, while effective, contributes to antimicrobial resistance, microbiota imbalance, and increased recurrence risk. Probiotics, particularly Lactobacillus crispatus, have demonstrated potential in restoring urogenital microbiota balance and reducing uropathogen overgrowth.

This study aims to assess whether CRISPACT® (Lactobacillus crispatus M247), administered orally, provides superior protection against rUTIs compared with standard care using iNatal Duo® alone. The study follows a randomized, controlled design with 84 participants allocated to two parallel arms. The Probiotic Group receives iNatal Duo® for 30 days combined with CRISPACT® for 90 days, while the Control Group receives iNatal Duo® alone for 30 days without additional probiotic supplementation.

The primary objective is to evaluate the reduction in rUTI recurrence over a 12-month follow-up period, assessed through clinical diagnosis and patient-reported data. Secondary objectives include evaluation of symptom relief, patient-reported quality-of-life outcomes (EQ-5D, King's Health Questionnaire), and safety and tolerability of the probiotic intervention. The study seeks to provide clinical evidence supporting probiotic-based strategies for rUTI prevention and reduction of antibiotic dependence.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Known hypersensitivity to study products.
• Failure to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

CRISPACT® Group

Experimental group

Description:

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.

Treatment:

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

Dietary Supplement: Lactobacillus crispatus M247

Control Group

Active Comparator group

Description:

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.

Treatment:

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