RECRUITING

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

Conditions

Uncomplicated Symptomatic Urinary Tract Infections

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2021-05-07

Study Completion:2023-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05793814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be able to give voluntary, written, informed consent to participate in the trial. 2. Be between 18-65, inclusive. 3. Has a BMI between 18.5 to 40 kg/m2, inclusive. 4. 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. 5. Willing to maintain existing dietary and physical activity patterns throughout the trial period. 6. Willing to comply with the trial protocol and consume the investigational product daily for the duration of the trial.	1. 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'). 2. Individuals with a history of UTIs who have experienced \>5 UTIs in the 6 months prior to their Baseline Visit (Week 0). 3. 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. 4. Individuals who are pregnant, breastfeeding, or wish to become pregnant during the trial. 5. Individuals currently of childbearing potential, but not using an effective method of contraception 6. 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). 7. 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). 8. 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). 9. 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. 10. 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). 11. Individuals with allergies or sensitivities to ingredients that would preclude intake of the investigational products. 12. 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. 13. 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.

Inclusion Criteria

Exclusion Criteria

1. Be able to give voluntary, written, informed consent to participate in the trial.
2. Be between 18-65, inclusive.
3. Has a BMI between 18.5 to 40 kg/m2, inclusive.
4. 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.
5. Willing to maintain existing dietary and physical activity patterns throughout the trial period.
6. Willing to comply with the trial protocol and consume the investigational product daily for the duration of the trial.

1. 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').
2. Individuals with a history of UTIs who have experienced \>5 UTIs in the 6 months prior to their Baseline Visit (Week 0).
3. 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.
4. Individuals who are pregnant, breastfeeding, or wish to become pregnant during the trial.
5. Individuals currently of childbearing potential, but not using an effective method of contraception
6. 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).
7. 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).
8. 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).
9. 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.
10. 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).
11. Individuals with allergies or sensitivities to ingredients that would preclude intake of the investigational products.
12. 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.
13. 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.

Contacts and Locations

Study Contact

Wafaa A Ayad, MD, PhD

CONTACT

6098061950

wafaa.ayad@churchdwight.com

Oliver Chen, PhD

CONTACT

6098061583

oliver.chen@churchdwight.com

Study Locations (Sites)

Church &Dwight., Inc

Princeton, New Jersey, 08543

United States

Collaborators and Investigators

Sponsor: Church & Dwight Company, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-07

Study Completion Date2023-06

Study Record Updates

Study Start Date2021-05-07

Study Completion Date2023-06

Terms related to this study

Additional Relevant MeSH Terms

Uncomplicated Symptomatic Urinary Tract Infections