Probiotics and Multi-Drug Resistant Urinary Tract Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

Conditions
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Urinary Tract Infections, Recurrent UTI, Antibiotic Resistant Infection

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium infantis
* Other: Placebo
* Drug: Antibiotics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic + Antibiotic<br>50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI. | Dietary Supplement: Bifidobacterium infantis<br>* Probiotics<br>* Other names: Align;Drug: Antibiotics<br>* Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women<br>|
| Active Comparator: Placebo + Antibiotic<br>50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI. | Other: Placebo<br>* Sugar pill manufactured to mimic probiotic tablet<br>* Other names: Placebo (for Probiotic);Drug: Antibiotics<br>* Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Resistance Pattern | The change in the quantity of antibiotics reported to be resistant per organism per culture per patient. | 6-8 weeks after initial dose | 
| Bacterial isolate genomic characteristics | genomic sequencing of bacterial isolates to determine genetic identity | 12 months after initial dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI reduction | The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline. | 12 months after initial dose | 
| Antibiotics Quantity | The quantity of antibiotics prescribed in treatment arm vs. placebo. | 12 months after initial dose | 
| Healthcare visit | The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo. | 12 months after initial dose | 
| Length of time for change in resistance | The amount of time it takes to note changes in antibiotic sensitivity patterns while on the treatment arm. | 12 months after initial dose | 
| Sensitivity pattern post-probiotic therapy | The change in the quantity of antibiotics reported to be resistant per organism | 12 months after initial dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, multi-drug resistant UTI, recurrent UTI