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Completed

NCT Number: NCT03644966

Probiotics and 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.

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Health System

Jefferson, Louisiana, 70121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifidobacterium infantis

Dietary Supplement

Probiotics

Other names: Align

Placebo

Other

Sugar pill manufactured to mimic probiotic tablet

Other names: Placebo (for Probiotic)

Antibiotics

Drug

Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women

Primary outcomes

  1. 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.

  2. Bacterial isolate genomic characteristics

    Time frame: 12 months after initial dose

    genomic sequencing of bacterial isolates to determine genetic identity

Secondary outcomes

  1. 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.

  2. Antibiotics Quantity

    Time frame: 12 months after initial dose

    The quantity of antibiotics prescribed in treatment arm vs. placebo.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • Procter and Gamble

Registry information

Official study title

Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2018
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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