Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention and Treatment of… (NCT06857565) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention and Treatment of Recurrent Urinary Tract Infections
Italy84 participantsStarted 2025-03-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of recurrent urinary tract infection (rUTI) episodes
Timeframe: 12 months
Trial details
NCT IDNCT06857565
SponsorLiaquat University of Medical & Health Sciences