Recruiting

Limosilactobacillus

Sponsor:

Church & Dwight Company, Inc.

Code:

NCT05793814

Conditions

Uncomplicated Symptomatic Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Limosilactobacillus reuteri 3613

Placebo

Study Details

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)

Conditions

Uncomplicated Symptomatic Urinary Tract Infections

Study ID

NCT05793814

Start date

May 7, 2021

Status verified date

Mar, 2023

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion 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.

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Exclusion Criteria:

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental: Limosilactobacillus Supplement

Capsules containing Probiotic taken daily for 6 month

placebo comparator: Placebo

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

Interventions

Limosilactobacillus reuteri 3613

Daily for 6 month

Placebo

Daily for 6 month

Primary outcome measure

  • Incidence rate of symptomatic UTI [ Time Frame: 6 months ]
  • Proportion of subjects experiencing ≥1 symptomatic UTI [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Church &Dwight., Inc

Recruiting

Princeton, New Jersey, United States, 08543

Contacts

More Information

Sponsor

Church & Dwight Company, Inc.

Last update posted

Mar 31, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Church & Dwight Company, Inc. on 2023-03-31.