Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250208
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2017-07-19
Brief Title:
Probiotics Effect on the Female Urinary Microbiome ProFUM Trial Probiotics Effect on the Female Urinary Microbiome
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
Probiotics and the Female Urinary Microbiome ProFUM Trial Probiotics Effect on the Female Urinary Microbiome
Status:
COMPLETED
Status Verified Date:
2019-01
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:
ProFUM
Brief Summary:
The study will enroll healthy pre-menopausal female volunteers in the community These subjects will act as their own controls The subjects will collect voided urine and peri-urethral swab specimens daily for several months They will also be asked to collect vaginal and peri-rectal swab specimens at various time points Subjects will document various lifestyle variables daily During the middle of the study subjects will be randomized to probiotic vs placebo Using bacterial culture and 16S rRNA gene sequencing the study will measure the bacterial populations of several anatomic sites longitudinally voided urine peri-urethra vagina and peri-rectal The study hypothesizes that oral probiotic usage will alter the bacterial populations and ratio of Lactobacillus to E coli within each of these sites Additionally the study hypothesizes that the changes within each site will occur first in the rectum ie GI tract followed by the vagina and then the urethra and bladder
Using the prospective design of daily sampling and lifestyle variable documentation the study may be able to identify possible influences on microbiome stability within the sampled sites The lifestyle variables recorded include diet medication usage menstruation sexual activity and alcohol consumption
This pilot study will establish the variance of the outcome variables among healthy women and confirm the emergence of the probiotic with the recommended dose With this information future researchers will be able to calculate the power needed for a larger randomized trial This trial would also randomize patients who may be at risk for a UTI to receive a probiotic vs placebo The primary outcome measurement will be the change in the ratio of Lactobacillus to E coli As a secondary aim the study will evaluate the incidence of UTI in the patients
Using the prospective design of daily sampling and lifestyle variable documentation the study may be able to identify possible influences on microbiome stability within the sampled sites The lifestyle variables recorded include diet medication usage menstruation sexual activity and alcohol consumption
This pilot study will establish the variance of the outcome variables among healthy women and confirm the emergence of the probiotic with the recommended dose With this information future researchers will be able to calculate the power needed for a larger randomized trial This trial would also randomize patients who may be at risk for a UTI to receive a probiotic vs placebo The primary outcome measurement will be the change in the ratio of Lactobacillus to E coli As a secondary aim the study will evaluate the incidence of UTI in the patients
Detailed Description:
In this study the primary aim is to identify the change in the Lactobacillus E coli ratio within the lower urinary tract the vagina and the peri-rectal area in response to an oral probiotic as well as to evaluate the stability of these changes following cessation of an oral probiotic Voided urine and peri-urethral vaginal and peri-rectal swab samples will be analyzed for their Lactobacillus E coli ratio using bacterial culture as well as 16S ribosomal RNA gene sequencing The study will compare the ratios present before during and after oral probiotic usage The study will also compare the change in ratios between subjects taking the oral probiotic and those taking an oral placebo
A secondary aim is to identify the normal daily changes ie stability in the bacterial populations within the voided urine including whether host intrinsic eg diet hygiene and sexual activity and extrinsic eg menstruation factors affect the stability of bacterial populations The bacterial populations defining the voided urine samples will be correlated to various daily subject-reported lifestyle variables These include diet hygiene sexual activity medication usage alcohol usage menstruation and urinary-related symptoms These lifestyle variables will be recorded each day for the entire duration of the study
A secondary aim is to identify the normal daily changes ie stability in the bacterial populations within the voided urine including whether host intrinsic eg diet hygiene and sexual activity and extrinsic eg menstruation factors affect the stability of bacterial populations The bacterial populations defining the voided urine samples will be correlated to various daily subject-reported lifestyle variables These include diet hygiene sexual activity medication usage alcohol usage menstruation and urinary-related symptoms These lifestyle variables will be recorded each day for the entire duration of the study
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