Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04077749
Status:
WITHDRAWN
Last Update Posted:
2021-07-08
First Post:
2019-08-28
Brief Title:
Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Sponsor:
Lahey Clinic
Organization:
Lahey Clinic
Study Overview
Official Title:
A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study never started It was withdrawn from the IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infochr-hansencom 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 patients urinary bladder for 30 minutes
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 infochr-hansencom 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 patients urinary bladder for 30 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None