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The goal of this clinical trial is to assess the efficacy of the probiotic Limosilactobacillus reuteri 3613 for the decrease or prevent UTI occurrence in women ages 18-65 with a confirmed medical history of recurrent uncomplicated UTIs compared to a Placebo (the study medication without the probiotic)
Adult women with a confirmed medical history of recurrent uncomplicated UTIs meeting all the eligibility criteria will be allocated in two study arms: test and placebo. Approximately 65 subjects per group will be enrolled to assure that approximately 50 subjects in each group complete the study. the study will be conducted in Ireland. The study will last approximately six month for each subject and will consist of 5 visits. The L. reuteri 3613 will be taken daily for 6 months and the frequency of UTIs will be assessed to determine the potential for the probiotic to decrease or prevent UTI occurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Limosilactobacillus Supplement | Experimental | Capsules containing Probiotic taken daily for 6 month |
|
| Placebo | Placebo Comparator | Capsules containing Microcrystalline cellulose, magnesium stearate taken Daily for 6 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limosilactobacillus reuteri 3613 | Dietary Supplement | Daily for 6 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of symptomatic UTI | To evaluate in healthy women who experience recurrent UTIs, the effect of 6 months of daily supplementation of the investigational product on incidence rate of symptomatic UTIs. | 6 months |
| Proportion of subjects experiencing ≥1 symptomatic UTI | Proportion of participants per product group experiencing ≥1 symptomatic UTI (as determined by urine culture) during the 6-month intervention period (from Baseline Visit [V2] to Final Visit [V5]). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| UTI symptom severity | Change in UTI symptom severity of participants with symptomatic UTI between product groups comparing Baseline (Week 0) with scores to scores at V 5 for | 6 months |
| Proportion of subjects experiencing different numbers of UTI |
| Measure | Description | Time Frame |
|---|---|---|
| Time for vaginal presence of the probiotic | To evaluate in healthy women who experience recurrent UTIs, the effect of 6 months of daily supplementation of the investigational product on the time it takes for the probiotic to reach the urogenital tract. The probiotic in vaginal samples will be measured visits 2-5. | 6 months |
Inclusion Criteria:
Be able to give voluntary, written, informed consent to participate in the trial.
Be between 18-65, inclusive.
Has a BMI between 18.5 to 40 kg/m2, inclusive.
Has a history of recurrent UTIs, defined as ≥ 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit (Visit 1), at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.
Willing to maintain existing dietary and physical activity patterns throughout the trial period.
Willing to comply with the trial protocol and consume the investigational product daily for the duration of the trial.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wafaa A Ayad, MD, PhD | Contact | 6098061950 | wafaa.ayad@churchdwight.com | |
| Oliver Chen, PhD | Contact | 6098061583 | oliver.chen@churchdwight.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Church &Dwight., Inc | Recruiting | Princeton | New Jersey | 08543 | United States |
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A Randomized, Double -Blind, Placebo-Controlled Study
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| Placebo | Dietary Supplement | Daily for 6 month |
|
Proportion of participants per product group experiencing 0, 1, 2, 3, or more symptomatic UTI during the 6-month intervention period from V2 to Final V5
| 6 months |
| Total UTI count | Difference in total number of UTIs per group (probiotic treatment compared to placebo group) during the 6-month intervention period from V2 to Final V5 | 6 months |
| Time for the first UTI | Difference in time from Day 0 to the first UTI occurrence between product groups, during the 6-month intervention period from Day 0 to V5 | 6 months |
| Vaginal pH change | Change in vaginal pH over time from Visit 2 to Visit 5, between product groups | 6 months |
| Quality of Life change | Change in Quality of Life questionnaire using Likert scale over time from Visit 2 to Visit 5, between product groups | 6 months |
| Vaginal microbiome |
Modulation of the vaginal microbiome analyzed using Shotgun metagenomic sequencing from Baseline (Week 0) to Visit 5 (Week 24) compared between groups. |
| 6 months |
| Vaginal presence of the probiotic | To evaluate the proportion of participants with vaginal swabs positive for the probiotic at Baseline (Visit 2) compared to Visit 5 (Week 24, end of intervention) between product groups. | 6 months |
| Safety assessment | Occurrence of any Adverse Events (AEs/SAEs). | 6 months |
| Tolerability | Vital signs (Blood Pressure, Heart Rate, and Temperature). | 6 months |
| ID | Term |
|---|---|
| D019936 | Probiotics |
| C100843 | Lacteol |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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