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

Lahey Health

Status and phase: Withdrawn; Early Phase 1

Conditions: Urinary Tract Infections

Treatments: Other: Normal Saline; Biological: Femdophilus probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04077749

2017-041

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Treatment:

Biological: Femdophilus probiotic

Placebo

Placebo Comparator group

Treatment:

Other: Normal Saline