Probiotics and Multi-Drug Resistant Urinary Tract Infection

Urinary Tract Infections Clinical Trial

Official title:

Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644966
• Other study ID #: 2017564
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Infections
• Recurrent UTI
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Bifidobacterium infantis
Probiotics

Other:
• Placebo
Sugar pill manufactured to mimic probiotic tablet

Drug:
• Antibiotics
Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women

Locations

Country	Name	City	State
United States	Ochsner Health System	Jefferson	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Procter and Gamble

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Resistance Pattern	The change in the quantity of antibiotics reported to be resistant per organism per culture per patient.	6-8 weeks after initial dose
Primary	Bacterial isolate genomic characteristics	genomic sequencing of bacterial isolates to determine genetic identity	12 months after initial dose
Secondary	UTI reduction	The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.	12 months after initial dose
Secondary	Antibiotics Quantity	The quantity of antibiotics prescribed in treatment arm vs. placebo.	12 months after initial dose
Secondary	Healthcare visit	The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo.	12 months after initial dose
Secondary	Length of time for change in resistance	The amount of time it takes to note changes in antibiotic sensitivity patterns while on the treatment arm.	12 months after initial dose
Secondary	Sensitivity pattern post-probiotic therapy	The change in the quantity of antibiotics reported to be resistant per organism	12 months after initial dose