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Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period

Primary Purpose

Uncomplicated Symptomatic Urinary Tract Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limosilactobacillus reuteri 3613
Placebo
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uncomplicated Symptomatic Urinary Tract Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Church &Dwight., IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Limosilactobacillus Supplement

Placebo

Arm Description

Capsules containing Probiotic taken daily for 6 month

Capsules containing Microcrystalline cellulose, magnesium stearate taken Daily for 6 month

Outcomes

Primary Outcome Measures

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.
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]).

Secondary Outcome Measures

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
Proportion of subjects experiencing different numbers of UTI
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
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
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
Vaginal pH change
Change in vaginal pH over time from Visit 2 to Visit 5, between product groups
Quality of Life change
Change in Quality of Life questionnaire using Likert scale over time from Visit 2 to Visit 5, between product groups

Full Information

First Posted
March 2, 2023
Last Updated
March 20, 2023
Sponsor
Church & Dwight Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05793814
Brief Title
Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Symptomatic Urinary Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Double -Blind, Placebo-Controlled Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Limosilactobacillus Supplement
Arm Type
Experimental
Arm Description
Capsules containing Probiotic taken daily for 6 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules containing Microcrystalline cellulose, magnesium stearate taken Daily for 6 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Limosilactobacillus reuteri 3613
Other Intervention Name(s)
Probiotics, Lactobacillus
Intervention Description
Daily for 6 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily for 6 month
Primary Outcome Measure Information:
Title
Incidence rate of symptomatic UTI
Description
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.
Time Frame
6 months
Title
Proportion of subjects experiencing ≥1 symptomatic UTI
Description
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]).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
UTI symptom severity
Description
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
Time Frame
6 months
Title
Proportion of subjects experiencing different numbers of UTI
Description
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
Time Frame
6 months
Title
Total UTI count
Description
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
Time Frame
6 months
Title
Time for the first UTI
Description
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
Time Frame
6 months
Title
Vaginal pH change
Description
Change in vaginal pH over time from Visit 2 to Visit 5, between product groups
Time Frame
6 months
Title
Quality of Life change
Description
Change in Quality of Life questionnaire using Likert scale over time from Visit 2 to Visit 5, between product groups
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Time for vaginal presence of the probiotic
Description
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.
Time Frame
6 months
Title
Vaginal microbiome
Description
Modulation of the vaginal microbiome analyzed using Shotgun metagenomic sequencing from Baseline (Week 0) to Visit 5 (Week 24) compared between groups.
Time Frame
6 months
Title
Vaginal presence of the probiotic
Description
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.
Time Frame
6 months
Title
Safety assessment
Description
Occurrence of any Adverse Events (AEs/SAEs).
Time Frame
6 months
Title
Tolerability
Description
Vital signs (Blood Pressure, Heart Rate, and Temperature).
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa A Ayad, MD, PhD
Phone
6098061950
Email
wafaa.ayad@churchdwight.com
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Chen, PhD
Phone
6098061583
Email
oliver.chen@churchdwight.com
Facility Information:
Facility Name
Church &Dwight., Inc
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08543
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wafaa A Ayad, MD, PhD
Phone
609-806-1950
Email
wafaa.ayad@churchdwight.com
First Name & Middle Initial & Last Name & Degree
Oliver Chen, PhD
Phone
609 806 1583
Email
oliver.chen@churchdwight.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period

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