NCT04077749

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

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lahey Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: [phone]; email: [e-mail]). 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

• Urinary Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	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.
OTHER	Normal Saline	50 mL normal saline at room temperature

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-30
• Completion: 2021-09-15
• First posted: 2019-09-04
• Last updated: 2021-07-08

Regulatory

• FDA-regulated drug study