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

NCT05793814 | Unknown

• 1 other identifier: AFCRO-138
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• UTI symptom severity

  6 months

• Proportion of subjects experiencing different numbers of UTI

  6 months

• Total UTI count

  6 months

• Time for the first UTI

  6 months

• Vaginal pH change

  6 months

Other Outcomes (5)

• Time for vaginal presence of the probiotic

  6 months

• Vaginal microbiome

  6 months

• Vaginal presence of the probiotic

  6 months

Study Arms (2)

Experimental: Limosilactobacillus Supplement

EXPERIMENTAL

Capsules containing Probiotic taken daily for 6 month

Dietary Supplement: Limosilactobacillus reuteri 3613

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Limosilactobacillus reuteri 3613 DIETARY_SUPPLEMENT

Daily for 6 month

Also known as: Probiotics, Lactobacillus

Experimental: Limosilactobacillus Supplement

Placebo DIETARY_SUPPLEMENT

Daily for 6 month

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Church &Dwight., Inc

Princeton, New Jersey, 08543, United States

RECRUITING

MeSH Terms

Interventions

Probiotics; Lacteol

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Wafaa A Ayad, MD, PhD

CONTACT

6098061950; wafaa.ayad@churchdwight.com

Oliver Chen, PhD

CONTACT

6098061583; oliver.chen@churchdwight.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double -Blind, Placebo-Controlled Study

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 31, 2023
• Study Start: May 7, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (1)