Probiotics and Multi-Drug Resistant Urinary Tract Infection



Status:Recruiting
Conditions:Other Indications, Infectious Disease, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other
Healthy:No
Age Range:18 - 90
Updated:8/25/2018
Start Date:July 5, 2018
End Date:November 29, 2019
Contact:Melissa Montgomery, MD
Email:memontgomery@ochsner.org
Phone:504-842-4083

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Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

This pilot study is a single-site randomized, double blinded placebo-controlled in females
with recurrent multi-drug resistant (MDR) urinary tract infections(UTI). Our study
hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these
former MDR UTIs.

The aims of this study are (1) to evaluate the effects of six months of probiotic therapy in
addition to standard of care in changing sensitivity patterns of MDR bacteria causing
recurrent UTI, (2) analyze the genetic composition of MDR bacterial isolates causing
recurrent UTI before and after administration of probiotic vs. placebo, with standard of care
antibiotics.

Study subjects will be asked to take a either a probiotic supplement or placebo at a dose of
1 caplet per day for 24 weeks in addition to antibiotic regimen. Subjects will be followed
for 12 months. The outcome measure is the percent of probiotic ingestors vs placebo ingestors
who experience a change in antibiotic susceptibility over this time period. The secondary
outcome measure is the evaluation of genetic composition of bacteria recurring after
probiotic vs. placebo administration.

Inclusion Criteria:

- Female, age 18-90

- Ability to void spontaneously

- Suffers from recurrent multi-drug resistant or extensively drug resistant urinary
tract infections caused by E.coli, Klebsiella, Enterococcus, Citrobacter, Proteus,
Enterobacter, Serratia and Providencia.

Exclusion Criteria:

- Has staghorn renal calculi, chronic hydronephrosis, intermittent catherization,
indwelling urinary catheters, urinary diversions, end stage renal disease on
hemodialysis, transplantation, HIV, cirrhosis, pancreatitis, allergy to soy or
milk/milk proteins or lactose intolerance

- Pregnant or breastfeeding

- Currently taking probiotics. 4 week washout.
We found this trial at
1
site
1221 South Clearview Parkway
Jefferson, Louisiana 70121
Principal Investigator: Melissa M Montgomery, MD
Phone: 504-842-9971
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mi
from
Jefferson, LA
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