Probiotics and Multi-Drug Resistant Urinary Tract Infection

April 10, 2023 updated by: Ochsner Health System

Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Ochsner Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic + Antibiotic
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
Probiotics
Other Names:
  • Align
Drug: Antibiotics
Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
Active Comparator: Placebo + Antibiotic
50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
Drug: Antibiotics
Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
Other: Placebo
Sugar pill manufactured to mimic probiotic tablet
Other Names:
  • Placebo (for Probiotic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Resistance Pattern
Time Frame: 6-8 weeks after initial dose
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
Time Frame: 12 months after initial dose
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
Time Frame: 12 months after initial dose
The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.
12 months after initial dose
Antibiotics Quantity
Time Frame: 12 months after initial dose
The quantity of antibiotics prescribed in treatment arm vs. placebo.
12 months after initial dose
Healthcare visit
Time Frame: 12 months after initial dose
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
Time Frame: 12 months after initial dose
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
Time Frame: 12 months after initial dose
The change in the quantity of antibiotics reported to be resistant per organism
12 months after initial dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Collaborators

Procter and Gamble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2018

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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