Clinical trial NCT03644966: Probiotics and Multi-Drug Resistant Urinary Tract Infection
Official title: Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Recurrent UTI
Antibiotic Resistant Infection
Keywords: Probiotics
multi-drug resistant UTI
recurrent UTI
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2018-08-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Resistance Pattern
timeFrame: 6-8 weeks after initial dose
measure: Bacterial isolate genomic characteristics
timeFrame: 12 months after initial dose
Secondary outcomes:
measure: UTI reduction
timeFrame: 12 months after initial dose
measure: Antibiotics Quantity
timeFrame: 12 months after initial dose
measure: Healthcare visit
timeFrame: 12 months after initial dose
measure: Length of time for change in resistance
timeFrame: 12 months after initial dose
measure: Sensitivity pattern post-probiotic therapy
timeFrame: 12 months after initial dose
Other outcomes:
Locations:
city: Jefferson
country: United States
facility: Ochsner Health System
state: Louisiana
Study officials:
References:
citation: Naderi A, Kasra-Kermanshahi R, Gharavi S, Imani Fooladi AA, Abdollahpour Alitappeh M, Saffarian P. Study of antagonistic effects of Lactobacillus strains as probiotics on multi drug resistant (MDR) bacteria isolated from urinary tract infections (UTIs). Iran J Basic Med Sci. 2014 Mar;17(3):201-8.
citation: Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
citation: Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998-2011. Open Forum Infect Dis. 2017 Feb 24;4(1):ofw281. doi: 10.1093/ofid/ofw281. eCollection 2017 Winter.
citation: Barclay J, Veeratterapillay R, Harding C. Non-antibiotic options for recurrent urinary tract infections in women. BMJ. 2017 Nov 23;359:j5193. doi: 10.1136/bmj.j5193. No abstract available.
citation: Vahedi-Shahandashti R, Kasra-Kermanshahi R, Shokouhfard M, Ghadam P, Feizabadi MM, Teimourian S. Antagonistic activities of some probiotic lactobacilli culture supernatant on Serratia marcescens swarming motility and antibiotic resistance. Iran J Microbiol. 2017 Dec;9(6):348-355.
citation: Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.
citation: Favier C, Neut C, Mizon C, Cortot A, Colombel JF, Mizon J. Fecal beta-D-galactosidase production and Bifidobacteria are decreased in Crohn's disease. Dig Dis Sci. 1997 Apr;42(4):817-22. doi: 10.1023/a:1018876400528.
citation: Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.