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

NCT04077749 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2021-07-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-06-30
Completion
2021-09-15
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077749 on ClinicalTrials.gov