Antibiotic Resistant Infection, Recurrent UTI, Urinary Tract Infections
Conditions
Keywords
Probiotics, multi-drug resistant UTI, recurrent UTI
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium infantis
Probiotics
OTHERPlacebo
Sugar pill manufactured to mimic probiotic tablet
DRUGAntibiotics
Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
Sponsors
Procter and Gamble
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resistance Pattern | 6-8 weeks after initial dose | The change in the quantity of antibiotics reported to be resistant per organism per culture per patient. |
| Bacterial isolate genomic characteristics | 12 months after initial dose | genomic sequencing of bacterial isolates to determine genetic identity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare visit | 12 months after initial dose | The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo. |
| UTI reduction | 12 months after initial dose | The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline. |
| Sensitivity pattern post-probiotic therapy | 12 months after initial dose | The change in the quantity of antibiotics reported to be resistant per organism |
| Length of time for change in resistance | 12 months after initial dose | The amount of time it takes to note changes in antibiotic sensitivity patterns while on the treatment arm. |
| Antibiotics Quantity | 12 months after initial dose | The quantity of antibiotics prescribed in treatment arm vs. placebo. |
Countries
United States
Outcome results
None listed