Ochsner Health System
Jefferson, Louisiana, 70121, United States
NCT Number: NCT03644966
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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Notify Me18 year–90 year
Female
Interventional
Not applicable
Jefferson, Louisiana, 70121, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotics
Other names: Align
Sugar pill manufactured to mimic probiotic tablet
Other names: Placebo (for Probiotic)
Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
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.
Time frame: 12 months after initial dose
genomic sequencing of bacterial isolates to determine genetic identity
Time frame: 12 months after initial dose
The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.
Time frame: 12 months after initial dose
The quantity of antibiotics prescribed in treatment arm vs. placebo.
Time frame: 12 months after initial dose
The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo.
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.
Time frame: 12 months after initial dose
The change in the quantity of antibiotics reported to be resistant per organism
Ochsner Health System
Other
Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection
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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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