Recurrent Urinary Tract InfectionNCT06857565
Study to Evaluate the Efficacy of Lactobacillus Crispatus M247 in the Prevention of Recurrent Urinary Tract Infections
A study testing Lactobacillus crispatus M247 and iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) in people with Recurrent Urinary Tract Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Lactobacillus crispatus M247 and iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2025to 11 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Complex Operating Unit of Surgical Gynecology and Pelvic Floor Reconstructive Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome (RM), 00168
About this study
Official title: Oral Lactobacillus Crispatus M247 as an Add-on to Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 for the Prevention of Recurrent Urinary Tract Infections in Women: A Prospective Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Lactobacillus crispatus M247, iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus M247Dietary supplement
CRISPACT® (Lactobacillus crispatus M247), PharmExtracta S.p.A
iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)Dietary supplement
iNatal-Duo®, PharmExtracta S.p.A
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
Change in urinary symptoms (King's Health Questionnaire)
Assessment using the King's Health Questionnaire (KHQ), a validated condition-specific questionnaire for urinary symptoms. Scores range from 0 to 100, with higher scores indicating worse symptom severity and impact on quality of life.
Measured: Baseline, 3 months
Pelvic pain and urgency/frequency symptom burden at month 3
Assessment using the Pelvic Pain and Urgency/Frequency (PUF) questionnaire. Total scores range from 0 to 35, with higher scores indicating greater symptom severity.
Measured: 3 months
Change in health-related quality of life (EQ-5D)
Assessment using the EuroQol 5-Dimension questionnaire (EQ-5D). The individual health dimensions and perceived health status were assessed separately.
Measured: Baseline, 3 months
Change in sexual function
Assessment using the Female Sexual Function Index-6 (FSFI-6). The available sexual-health measures were assessed separately.
Measured: Baseline, 3 months
Treatment adherence
Proportion of participants taking at least 90% of the scheduled doses of the assigned probiotic supplementation, assessed using participants' treatment diaries and counts of returned unused sachets.
Measured: 3 months
Treatment tolerability
Participants' overall assessment of treatment tolerability, categorized as excellent, good, fair, or poor, together with the number of treatment discontinuations.
Measured: 3 months
Safety and adverse events
Number and proportion of participants experiencing adverse events, serious adverse events, vaginitis, bacterial vaginosis, or other genital infections during the study.
Measured: 12 months
Cumulative number of symptomatic UTI recurrences per participant through month 3
Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 3-month assessment.
Measured: 3 months
Participants experiencing at least one symptomatic UTI recurrence through month 3
Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence from randomization through the 3-month assessment.
Measured: 3 months
Participants experiencing at least one symptomatic UTI recurrence through month 12
Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence from randomization through the 12-month assessment.
Measured: 12 months
Participants requiring culture-guided antibiotic therapy for a symptomatic UTI recurrence
Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence whose symptoms did not improve to a clinically meaningful extent within 3 days of an initial non-antibiotic regimen. This regimen comprised oral D-mannose 500 mg three times daily, taken after voiding and away from meals, together with ibuprofen 400 mg once daily in the morning after breakfast, with a second 400-mg dose 12 hours later when required. Participants reporting an allergy to ibuprofen received paracetamol 1,000 mg once daily, with a second 1,000-mg dose 12 hours later when required. Participants without clinically meaningful improvement by day 3 received antibiotic therapy selected according to urine-culture and antimicrobial-susceptibility results. The denominator was the number of participants experiencing at least one confirmed recurrence; each participant was counted only once if antibiotic therapy was required for any recurrence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 Mar 2025
- Primary completion11 Apr 2026
- Study completion11 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857565
- Sponsor's protocol ID
- 0038288/22/07.12.2022
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lactobacillus Crispatus M247 as an Add-on to Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 for the Prevention of Recurrent Urinary Tract Infections in Women: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06857565
- Acronym / sponsor ID
- 0038288/22/07.12.2022
- Conditions
- Recurrent Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 11 Apr 2026 (actual)
- Study completion
- 11 Apr 2026 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| CRISPACT® Group | Experimental | Dietary Supplement: Lactobacillus crispatus M247, Dietary Supplement: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)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. |
| Control Group | Active comparator | Dietary Supplement: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus crispatus M247CRISPACT® (Lactobacillus crispatus M247), PharmExtracta S.p.A | Dietary supplement | CRISPACT® Group |
| iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3)iNatal-Duo®, PharmExtracta S.p.A | Dietary supplement | CRISPACT® Group, Control Group |
Primary outcome
Cumulative number of symptomatic UTI recurrences per participant
Time frame: 12 months
Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 12-month follow-up
11 secondary outcomes
Change in urinary symptoms (King's Health Questionnaire)
Time frame: Baseline, 3 months
Pelvic pain and urgency/frequency symptom burden at month 3
Time frame: 3 months
Change in health-related quality of life (EQ-5D)
Time frame: Baseline, 3 months
Change in sexual function
Time frame: Baseline, 3 months
Treatment adherence
Time frame: 3 months
Treatment tolerability
Time frame: 3 months
Safety and adverse events
Time frame: 12 months
Cumulative number of symptomatic UTI recurrences per participant through month 3
Time frame: 3 months
Participants experiencing at least one symptomatic UTI recurrence through month 3
Time frame: 3 months
Participants experiencing at least one symptomatic UTI recurrence through month 12
Time frame: 12 months
Participants requiring culture-guided antibiotic therapy for a symptomatic UTI recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus crispatus M247 and iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) in people with Recurrent Urinary Tract Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of symptomatic UTI recurrences per participant (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.