Probiotics and Multi-Drug Resistant Urinary Tract Infection

Ochsner Health System

Status: Completed

Conditions: Urinary Tract Infections; Antibiotic Resistant Infection; Recurrent UTI

Treatments: Dietary Supplement: Bifidobacterium infantis; Other: Placebo; Drug: Antibiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03644966

2017564

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Probiotic + Antibiotic

Experimental group

Description:

50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.

Treatment:

Drug: Antibiotics

Dietary Supplement: Bifidobacterium infantis

Placebo + Antibiotic

Active Comparator group

Description:

50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.

Treatment:

Other: Placebo

Drug: Antibiotics