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Status unknownNCT05793814Updated Mar 31, 2023

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

An interventional study of Limosilactobacillus reuteri 3613 and Placebo in Uncomplicated Symptomatic Urinary Tract Infections, sponsored by Church & Dwight Company, Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Church & Dwight Company, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled May 2021, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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)

Read the 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.

02

Conditions studied

  • Uncomplicated Symptomatic Urinary Tract Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 130 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Exclusion criteria

-

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Experimental: Limosilactobacillus Supplement

    Capsules containing Probiotic taken daily for 6 month

    Dietary Supplement: Limosilactobacillus reuteri 3613

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementLimosilactobacillus reuteri 3613

    Daily for 6 month

    Also known as: Probiotics, Lactobacillus

  • Dietary supplementPlacebo

    Daily for 6 month

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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 \[V5\]).

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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 frame: 6 months

  4. 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

    Time frame: 6 months

  5. Vaginal pH change

    Change in vaginal pH over time from Visit 2 to Visit 5, between product groups

    Time frame: 6 months

  6. Quality of Life change

    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 outcomes

  1. Time for vaginal presence of the probiotic

    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

  2. Vaginal microbiome

    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

  3. Vaginal presence of the probiotic

    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

  4. Safety assessment

    Occurrence of any Adverse Events (AEs/SAEs).

    Time frame: 6 months

  5. Tolerability

    Vital signs (Blood Pressure, Heart Rate, and Temperature).

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05793814
Lead sponsor
Church & Dwight Company, Inc.
Responsible party
Sponsor
First posted
Mar 31, 2023
Start date
May 7, 2021
Primary completion
Jun 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Mar 31, 2023

Study contacts

Wafaa A Ayad, MD, PhD
Contact
wafaa.ayad@churchdwight.com
6098061950
Oliver Chen, PhD
Contact
oliver.chen@churchdwight.com
6098061583

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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