Probiotics Effect on 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.