Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period
NCT ID: NCT05793814
Last Updated: 2023-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2021-05-07
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental: Limosilactobacillus Supplement
Capsules containing Probiotic taken daily for 6 month
Limosilactobacillus reuteri 3613
Daily for 6 month
Placebo
Capsules containing Microcrystalline cellulose, magnesium stearate taken Daily for 6 month
Placebo
Daily for 6 month
Interventions
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Limosilactobacillus reuteri 3613
Daily for 6 month
Placebo
Daily for 6 month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
FEMALE
No
Sponsors
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Church & Dwight Company, Inc.
INDUSTRY
Responsible Party
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Locations
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Church &Dwight., Inc
Princeton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Wafaa A Ayad, MD, PhD
Role: primary
Oliver Chen, PhD
Role: backup
Other Identifiers
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AFCRO-138
Identifier Type: -
Identifier Source: org_study_id