Probiotics Effect on the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome) (ProFUM)

January 31, 2019 updated by: Elizabeth Mueller, Loyola University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pre-menopausal healthy women in the community (As defined by presence of menses at least once in the last 12 months).
  • Age 18 years or older.
  • Agreement to collect daily samples (varying combinations of voided, periurethral, and perianal swabs) for 3 months and bring the samples to Loyola University Medical Center
  • Agree to record and return a daily lifestyle diary
  • Understand and agree to taking daily oral probiotic or placebo while being blinded
  • Able to read and speak English
  • Able to obtain clean-catch urine

Exclusion Criteria:

  • Non-English speaking women
  • Allergy or contraindication to the probiotic used in this study
  • Prior participation in the study
  • Currently pregnant or lactating or planning a pregnancy within 6 months of consenting to participate in the study
  • Inability to obtain a 'clean catch' urine sample
  • Subjects with an indwelling catheter
  • Males are excluded from participation
  • Women planning time away for more than 7 days following consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Participants randomized to this group will take two placebo capsules daily during days 21-60.
Other: Placebo
Participants randomized to the control group will receive a placebo containing no active ingredients
Other Names:
  • Inactive substance
Experimental: Intervention group
The intervention in this study is a probiotic. Participants randomized to this group will take two capsules of a probiotic daily during days 21-60
Dietary supplement: Probiotic
Participants randomized to the intervention group will receive Women's Fem Dophilus ® by Jarrow Formulas.
Other Names:
  • Fem Dophilus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lactobacillus E. coli ratio in the rectum
Time Frame: 95 days
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.
95 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lactobacillus E. coli ratio in the vagina
Time Frame: 95 days
We will measure participants' vaginal 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.
95 days
Change in Lactobacillus E. coli ratio in the urethra
Time Frame: 95 days
We will measure participants' urethral 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.
95 days
Prevalence of urinary tract infections
Time Frame: 95 days
At the final study visit, we will record whether each participant experienced or did not experience a urinary tract infection (UTI). The odds of a UTI among those in the intervention cohort will be compared to the odds of a UTI in the placebo cohort.
95 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Elizabeth Mueller, MD, Loyola University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 209830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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