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 |
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.
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.
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
Jefferson, Louisiana 70121
Principal Investigator: Melissa M Montgomery, MD
Phone: 504-842-9971
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