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Urinary Tract InfectionsNCT03644966

Probiotics and Multi-Drug Resistant Urinary Tract Infection

A study testing Bifidobacterium infantis and Antibiotics in people with Urinary Tract Infections and Recurrent UTI, run by Ochsner Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years, women onlyHealthy volunteers can take part
What is being tested?
Bifidobacterium infantis and Antibiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
5 Jul 2018to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ochsner Health System

    Jefferson, Louisiana, 70121

Other trials in United States

About this study

Official title: Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection

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.

Read the 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.

Being tested
Bifidobacterium infantis, Placebo, Antibiotics
Keywords
Probiotics, multi-drug resistant UTI, recurrent UTI
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bifidobacterium infantisDietary supplement

    Also called Align

    Probiotics

  • PlaceboOther

    Also called Placebo (for Probiotic)

    Sugar pill manufactured to mimic probiotic tablet

  • AntibioticsDrug

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

Study groups in NCT03644966
Study groupRoleWhat they receive
Probiotic + AntibioticExperimental50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.
Receives: Dietary Supplement: Bifidobacterium infantis; Drug: Antibiotics
Placebo + AntibioticActive comparator50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
Receives: Other: Placebo; Drug: Antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Resistance Pattern

    The change in the quantity of antibiotics reported to be resistant per organism per culture per patient.

    Measured: 6-8 weeks after initial dose

  2. Bacterial isolate genomic characteristics

    genomic sequencing of bacterial isolates to determine genetic identity

    Measured: 12 months after initial dose

Secondary outcomes (5)

  1. UTI reduction

    The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.

    Measured: 12 months after initial dose

  2. Antibiotics Quantity

    The quantity of antibiotics prescribed in treatment arm vs. placebo.

    Measured: 12 months after initial dose

  3. Healthcare visit

    The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo.

    Measured: 12 months after initial dose

  4. 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.

    Measured: 12 months after initial dose

  5. Sensitivity pattern post-probiotic therapy

    The change in the quantity of antibiotics reported to be resistant per organism

    Measured: 12 months after initial dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start5 Jul 2018
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03644966
Sponsor's protocol ID
2017564
Status last verified
Apr 2023
First submitted
6 Aug 2018
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24847423

  • 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.

    PubMed 26695595

  • 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.

    PubMed 28480273

  • 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.

    PubMed 29170359

  • 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.

    PubMed 29487733

  • 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.

    PubMed 26955289

  • 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.

    PubMed 9125655

  • 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.

    PubMed 21292654

Questions about this trial

What is this clinical trial studying?

A study testing Bifidobacterium infantis and Antibiotics in people with Urinary Tract Infections and Recurrent UTI, run by Ochsner Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Resistance Pattern (time frame: 6-8 weeks after initial dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03644966, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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