Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05230511
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2022-01-28
Brief Title:
Intravesical LGG VS Saline Bladder Wash RCT
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash A Randomized Controlled Comparative Effectiveness Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection UTI
Detailed Description:
Urinary tract infection UTI is the most common outpatient infection world-wide and for people with spinal cord injury SCI and neurogenic bladder NB it is the most common infection secondary condition cause for emergency room visits and infectious cause of hospitalization Despite its prevalence attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around gold standard diagnostic tests urinalysis and urine culture that have lower sensitivity and specificity for UTI in this population A high prevalence of chronic inflammation leading to persistence of white blood cells WBC in the urine confounds the utility of WBC count pyuria and leukocyte esterase as biomarkers for UTI nitrites in urine indicate the presence of only specific but not all organisms many of which are present to a greater extent in the urine of people with SCI and people with SCI have a high prevalence of asymptomatic bacteriuria These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI
SPECIFIC AIM 1 Compare the effects of Lactobacillus Rhamnosus GG LGG Saline bladder wash BW versus BW alone on USQNB-determined bladder B1 and urine quality B2 symptom burden two co-primary outcomes where participants self-manage in response to two trigger symptoms cloudier andor more foul-smelling urine
SPECIFIC AIM 2 Compare the effects of LGGBW versus BW alone in response to the two trigger symptoms on key secondary outcomes number of days lost from rehabilitation work andor school number of days symptomatic number of interactions with the health care system due to urinary symptoms exposure to antibiotics days volume
SPECIFIC AIM 3 Compare the prophylactic effects of LGGBW versus BW alone on USQNB-determined bladder B1 and urine quality B2 symptom burden
SPECIFIC AIM 4 Compare the prophylactic effects of LGGBW versus BW alone on key secondary outcomes number of days lost from rehabilitation work andor school number of days symptomatic number of interactions with the health care system due to urinary symptoms exposure to antibiotics days volume
SPECIFIC AIM 5 Compare satisfaction of participants who instilled LGGBW to satisfaction of those who instilled BW only and determine if dropouts are differentially attributable to either intervention being perceived by participants as not working
SPECIFIC AIM 1 Compare the effects of Lactobacillus Rhamnosus GG LGG Saline bladder wash BW versus BW alone on USQNB-determined bladder B1 and urine quality B2 symptom burden two co-primary outcomes where participants self-manage in response to two trigger symptoms cloudier andor more foul-smelling urine
SPECIFIC AIM 2 Compare the effects of LGGBW versus BW alone in response to the two trigger symptoms on key secondary outcomes number of days lost from rehabilitation work andor school number of days symptomatic number of interactions with the health care system due to urinary symptoms exposure to antibiotics days volume
SPECIFIC AIM 3 Compare the prophylactic effects of LGGBW versus BW alone on USQNB-determined bladder B1 and urine quality B2 symptom burden
SPECIFIC AIM 4 Compare the prophylactic effects of LGGBW versus BW alone on key secondary outcomes number of days lost from rehabilitation work andor school number of days symptomatic number of interactions with the health care system due to urinary symptoms exposure to antibiotics days volume
SPECIFIC AIM 5 Compare satisfaction of participants who instilled LGGBW to satisfaction of those who instilled BW only and determine if dropouts are differentially attributable to either intervention being perceived by participants as not working
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