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Trial record 33 of 160 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Probiotics and Multi-Drug Resistant Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT03644966
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Melissa Montgomery, MD, Ochsner Health System

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Recurrent UTI Antibiotic Resistant Infection Dietary Supplement: Bifidobacterium infantis Other: Placebo Drug: Antibiotics Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : May 29, 2019
Estimated Study Completion Date : November 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic + Antibiotic
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 infantis
Probiotics
Other Name: Align

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

Active Comparator: Placebo + Antibiotic
50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
Other: Placebo
Sugar pill manufactured to mimic probiotic tablet
Other Name: Placebo (for Probiotic)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644966


Contacts
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Contact: Melissa Montgomery, MD 504-842-4083 memontgomery@ochsner.org
Contact: Mhy-Lanie Adduru, MD 504-842-9971 mhylanie.adduru@ochsner.org

Locations
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United States, Louisiana
Ochsner Health System Recruiting
Jefferson, Louisiana, United States, 70121
Contact: Mhy-Lanie Adduru, MD    504-842-9971    mhylanie.adduru@ochsner.org   
Contact: Maria Latsis    504-842-3115    mlatsis@ochsner.org   
Principal Investigator: Melissa M Montgomery, MD         
Sub-Investigator: Joanna Togami, MD         
Sponsors and Collaborators
Ochsner Health System
Procter and Gamble

Publications:

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Responsible Party: Melissa Montgomery, MD, Urologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03644966     History of Changes
Other Study ID Numbers: 2017564
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa Montgomery, MD, Ochsner Health System:
Probiotics
multi-drug resistant UTI
recurrent UTI

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents