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NCT03250208 · ClinicalTrials.gov registry record · NA
Probiotics Effect on the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
A NA study, sponsored by Loyola University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT03250208: Completed NA study, sponsored by Loyola University.
NCT03250208 is a NA study that has completed, run by Loyola University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03250208, a NA study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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 (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.
Primary Outcome
We will measure participants' rectal Lactobacillus E. coli ratio at baseline and after treatment. The change in this ratio will be recorded for each participant and compared between the placebo and intervention groups.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Probiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2018-07-31 |
| Phase | NA |
What the finished NCT03250208 record still lists
NCT03250208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03250208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03250208 about?
NCT03250208 is a clinical study titled "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 ...
What is the current status of trial NCT03250208?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2017-09-01. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT03250208?
The interventions under investigation include: Placebo (OTHER), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03250208?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03250208's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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