Probiotics and Multi-Drug Resistant Urinary Tract Infection

Not Applicable

Completed

• Conditions: Urinary Tract Infections; Recurrent UTI; Antibiotic Resistant Infection
• Interventions: Dietary Supplement: Bifidobacterium infantis; Other: Placebo; Drug: Antibiotics

• Registration Number: NCT03644966
• Lead Sponsor: Ochsner Health System

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.

Study Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic + Antibiotic	Bifidobacterium infantis	50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.
Probiotic + Antibiotic	Antibiotics	50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.
Placebo + Antibiotic	Placebo	50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
Placebo + Antibiotic	Antibiotics	50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sensitivity pattern post-probiotic therapy	12 months after initial dose	The change in the quantity of antibiotics reported to be resistant per organism
UTI reduction	12 months after initial dose	The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.
Antibiotics Quantity	12 months after initial dose	The quantity of antibiotics prescribed in treatment arm vs. placebo.
Healthcare visit	12 months after initial dose	The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo.
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.

Trial Locations

Locations (1)

Ochsner Health System; 🇺🇸 Jefferson, Louisiana, United States