Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Consumption of a Limosilactobacillus Supplement on Recurrence of Uncomplicated Symptomatic Urinary Tract Infections (UTI) in Healthy Women During a 6-month Period
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Wafaa A Ayad, MD, PhD
- Phone Number: 6098061950
- Email: wafaa.ayad@churchdwight.com
Study Contact Backup
- Name: Oliver Chen, PhD
- Phone Number: 6098061583
- Email: oliver.chen@churchdwight.com
Study Locations
-
-
New Jersey
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Princeton, New Jersey, United States, 08543
- Recruiting
- Church &Dwight., Inc
-
Contact:
- Wafaa A Ayad, MD, PhD
- Phone Number: 609-806-1950
- Email: wafaa.ayad@churchdwight.com
-
Contact:
- Oliver Chen, PhD
- Phone Number: 609 806 1583
- Email: oliver.chen@churchdwight.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
-
Exclusion Criteria:
- Individuals who are on unstable medications (defined as prescribed medications which in the opinion of the investigator may impact the outcomes of the study (defined as prescribed medications for which participant only takes periodically or 'as needed').
- Individuals with a history of UTIs who have experienced >5 UTIs in the 6 months prior to their Baseline Visit (Week 0).
- Participants with clinically significant abnormal laboratory results at their screening visit (from urine culture, urinalysis, and safety blood assessments) which, in the opinion of the investigator, would impact the efficacy of the trial or the safety of the participant.
- Individuals who are pregnant, breastfeeding, or wish to become pregnant during the trial.
- Individuals currently of childbearing potential, but not using an effective method of contraception
- Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within the previous 30 days prior to their Baseline Visit (Visit 2).
- Individuals with a current history of drug abuse (self-report) and/or alcohol abuse (>2 standard alcoholic drinks per day) within the 6 months prior to Baseline Visit (Visit2).
- Uses tobacco or smoking-related products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches).
- Individuals currently consuming an extremely restrictive diet, or in the previous 3 months prior to their Baseline Visit or planning to consume a restrictive diet during the trial.
- Individuals who are not willing to adhere to dietary/supplement restrictions listed in the trial protocol (refrain from consumption of probiotic supplements, prebiotics, cranberry supplements, and D-mannose supplements; limit consumption of yoghurt, fermented foods, and cranberries to no more than once per week).
- Individuals with allergies or sensitivities to ingredients that would preclude intake of the investigational products.
- Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to their Screening Visit (Visit 1) for this trial.
- Individuals that have a significant acute or chronic coexisting illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease, severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer, or HIV, or any condition which contraindicates, in the investigator's judgement, entry to the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Experimental: Limosilactobacillus Supplement
Capsules containing Probiotic taken daily for 6 month
|
Daily for 6 month
Other Names:
|
|
Placebo Comparator: Placebo
Capsules containing Microcrystalline cellulose, magnesium stearate taken Daily for 6 month
|
Daily for 6 month
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence rate of symptomatic UTI
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UTI symptom severity
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Change in vaginal pH over time from Visit 2 to Visit 5, between product groups
|
6 months
|
|
Quality of Life change
Time Frame: 6 months
|
Change in Quality of Life questionnaire using Likert scale over time from Visit 2 to Visit 5, between product groups
|
6 months
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for vaginal presence of the probiotic
Time Frame: 6 months
|
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
|
|
Vaginal microbiome
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Occurrence of any Adverse Events (AEs/SAEs).
|
6 months
|
|
Tolerability
Time Frame: 6 months
|
Vital signs (Blood Pressure, Heart Rate, and Temperature).
|
6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AFCRO-138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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