Back to results

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

Primary Purpose

Urinary Tract Infections

Status

Withdrawn

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Femdophilus probiotic

Normal Saline

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Bladder colonization with Lactobacillus

Percent of patients with urine cultures positive for lactobacilli species after 6 months.

Secondary Outcome Measures

Full Information

NCT ID

NCT04077749

First Posted

August 28, 2019

Last Updated

July 2, 2021

Sponsor

Lahey Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04077749

Brief Title

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

Official Title

A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

The study never started. It was withdrawn from the IRB.

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lahey Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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: info@chr-hansen.com). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Femdophilus probiotic

Intervention Description

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

Other

Intervention Name(s)

Normal Saline

Intervention Description

50 mL normal saline at room temperature

Primary Outcome Measure Information:

Title

Bladder colonization with Lactobacillus

Description

Percent of patients with urine cultures positive for lactobacilli species after 6 months.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 18 years of age Chronic indwelling urethral catheter or supra-pubic tube for >6 months Prior symptomatic UTI while catheter in place Exclusion Criteria: Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes) Active infection (may be considered after treatment of active infection) Prior urosepsis requiring ICU admission Significant gross hematuria resulting from catheter exchanges Supravesical urinary diversion Upper urinary tract anatomical abnormality Obstructing urolithiasis Ongoing antibiotic therapy for non-urological infection Indwelling nephrostomy tube or ureteral stent Radiation cystitis Pregnancy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs