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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04077749
• Other study ID #: 2017-041
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 1, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: July 2021
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder colonization with Lactobacillus	Percent of patients with urine cultures positive for lactobacilli species after 6 months.	6 months