Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-09-15

Brief Summary

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The proposed study is a randomized, placebo-controlled clinical trial to test the efficacy of an oral Lactobacillus product dissolved in sterile saline and instilled into the urinary bladder in an attempt to colonize the urinary bladder as well as prevent UTIs.

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Detailed Description

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Patients who use a chronic indwelling urinary catheter to drain their bladder will be randomized to receive intravesical instillations of a Lactobacillus solution or sterile saline at the time of a scheduled monthly catheter exchange. Bacterial colonization and frequency of urinary tract infections will be compared between the two groups.

The Lactobacillus solution will be derived from the combination of Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus and manufactured by CHR-Hansen of Denmark (phone: +45 45747474; email: [email protected]). The contents of the capsules will be dissolved in 50 mL of normal saline at room temperature within one hour prior to administration and left indwelling in the patient's urinary bladder for 30 minutes.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic

Group Type EXPERIMENTAL

Femdophilus probiotic

Intervention Type BIOLOGICAL

Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus dissolved in 50 mL normal saline at room temperature.

Placebo

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

50 mL normal saline at room temperature

Interventions

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Femdophilus probiotic

Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus dissolved in 50 mL normal saline at room temperature.

Intervention Type BIOLOGICAL

Normal Saline

50 mL normal saline at room temperature

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age
2. Chronic indwelling urethral catheter or supra-pubic tube for \>6 months
3. Prior symptomatic UTI while catheter in place

Exclusion Criteria

1. Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes)
2. Active infection (may be considered after treatment of active infection)
3. Prior urosepsis requiring ICU admission
4. Significant gross hematuria resulting from catheter exchanges
5. Supravesical urinary diversion
6. Upper urinary tract anatomical abnormality
7. Obstructing urolithiasis
8. Ongoing antibiotic therapy for non-urological infection
9. Indwelling nephrostomy tube or ureteral stent
10. Radiation cystitis
11. Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes