Healthy Clinical Trial
Official title:
Probiotics and the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
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 (i.e. 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.
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 (i.e. stability) in the bacterial
populations within the voided urine, including whether host intrinsic (e.g. diet, hygiene,
and sexual activity) and extrinsic (e.g. 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.
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