Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793814
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-02
Brief Title:
Assess the Effects of a Limosilactobacillus Supplement on Recurrence of UTI in Healthy Women During a 6-month Period
Sponsor:
Church Dwight Company Inc
Organization:
Church Dwight Company Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess the Effects of Consumption of a Limosilactobacillus Supplement on Recurrence of Uncomplicated Symptomatic Urinary Tract Infections UTI in Healthy Women During a 6-month Period
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None