Status:
COMPLETED
Probiotics Effect on the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)
Lead Sponsor:
Loyola University
Conditions:
Healthy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 wel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03250208
Start Date
September 1 2017
End Date
July 31 2018
Last Update
February 1 2019
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153