NCT03644966

Probiotics and Multi-Drug Resistant Urinary Tract Infection

Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Tract Infections
• Recurrent UTI
• Antibiotic Resistant Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium infantis	Probiotics
OTHER	Placebo	Sugar pill manufactured to mimic probiotic tablet
DRUG	Antibiotics	Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women

Timeline

• Start date: 2018-07-05
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2018-08-23
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States