NCT03644966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4.4 years

First QC Date

August 6, 2018

Last Update Submit

April 10, 2023

Conditions

Urinary Tract InfectionsRecurrent UTIAntibiotic Resistant Infection

Keywords

Probioticsmulti-drug resistant UTIrecurrent UTI

Outcome Measures

Primary Outcomes (2)

  • 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

  • Bacterial isolate genomic characteristics

    genomic sequencing of bacterial isolates to determine genetic identity

    12 months after initial dose

Secondary Outcomes (5)

  • UTI reduction

    12 months after initial dose

  • Antibiotics Quantity

    12 months after initial dose

  • Healthcare visit

    12 months after initial dose

  • Length of time for change in resistance

    12 months after initial dose

  • Sensitivity pattern post-probiotic therapy

    12 months after initial dose

Study Arms (2)

Probiotic + Antibiotic

EXPERIMENTAL

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 infantisDrug: Antibiotics

Placebo + Antibiotic

ACTIVE COMPARATOR

50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.

Other: PlaceboDrug: Antibiotics

Interventions

Bifidobacterium infantisDIETARY_SUPPLEMENT

Probiotics

Also known as: Align
Probiotic + Antibiotic
PlaceboOTHER

Sugar pill manufactured to mimic probiotic tablet

Also known as: Placebo (for Probiotic)
Placebo + Antibiotic
AntibioticsDRUG

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

Placebo + AntibioticProbiotic + Antibiotic

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Health System

Jefferson, Louisiana, 70121, United States

Location

Related Publications (8)

  • 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.

    PMID: 24847423BACKGROUND

  • 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.

    PMID: 26695595BACKGROUND

  • 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.

    PMID: 28480273BACKGROUND

  • 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.

    PMID: 29170359BACKGROUND

  • 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.

    PMID: 29487733BACKGROUND

  • 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.

    PMID: 26955289BACKGROUND

  • 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.

    PMID: 9125655BACKGROUND

  • 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.

    PMID: 21292654BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 23, 2018

Study Start

July 5, 2018

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)