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

Early Phase 1

Withdrawn

• Conditions: Urinary Tract Infections
• Interventions: Other: Normal Saline; Biological: Femdophilus probiotic

• Registration Number: NCT04077749
• Lead Sponsor: Lahey Clinic

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.

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-04
• Study Start: 2021-04-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-08
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline	-
Probiotic	Femdophilus probiotic	-

Primary Outcome Measures

Name	Time	Method
Bladder colonization with Lactobacillus	6 months	Percent of patients with urine cultures positive for lactobacilli species after 6 months.