Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women Duri… (NCT05793814) | Clinical Trial Compass
UnknownNot Applicable
Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period
United States130 participantsStarted 2021-05-07
Plain-language 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)
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕
What they're measuring
1
Incidence rate of symptomatic UTI
Timeframe: 6 months
2
Proportion of subjects experiencing ≥1 symptomatic UTI
. 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).