NCT Number: NCT05230511
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Allison M Maxwell, BA
CONTACT
Inger H Ljungberg, MPH
CONTACT
Suzanne Groah, MD, MSPH
PRINCIPAL_INVESTIGATOR
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 and/or more foul-smelling urine).
SPECIFIC AIM 2 Compare the effects of LGG®+BW versus BW alone (in response to the two trigger symptoms) on key secondary outcomes: number of days lost from rehabilitation, work, and/or 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 LGG®+BW versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden.
SPECIFIC AIM 4 Compare the prophylactic effects of LGG®+BW versus BW alone on key secondary outcomes: number of days lost from rehabilitation, work, and/or 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 LGG®+BW 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".
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
Other names: Culturelle Probiotic LGG®
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
Time frame: Day 1
A tool that describes urinary tract impairment, awareness of need to empty bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year. Score is not associated with outcome.
Time frame: Day 1
Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.
Time frame: Day 1
A brief medical history using body system categories. Score is not associated with outcomes.
Time frame: Day 1
Contains whether or not the participant is taking a medication during the study protocol, name of the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.
Time frame: (SA1 and SA3) Weekly up to 18 months
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Time frame: (SA1) Day 1 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Time frame: (SA1) Day 2 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Time frame: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Time frame: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
We developed a simple three-item patient satisfaction "survey" that will be requested from only those individuals who used the intervention (LGG® +BW or BW only) at the time of final USQNB-IC completion, or at the drop out visit (for those who did use the intervention at least once). Participants will be asked to estimate, using a scale from 0% <totally dissatisfied/would absolutely never do this>, through 50% <neither satisfied nor dissatisfied/might do this> to 100% <completely satisfied/would absolutely always do this>:
Contact information is provided by the study sponsor or research team.
Emily Leonard, PhD
CONTACT
Inger H Ljungberg, MPH
CONTACT
Medstar Health Research Institute
Other
Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07390591
Central Nervous System Diseases, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT06515223
Central Nervous System Diseases, Colonic Diseases
Stanmore, United Kingdom
View Trial DetailsNCT04936217
Central Nervous System Diseases, Female Urogenital Diseases
Nîmes, Gard, France
View Trial DetailsNCT04248322
Central Nervous System Diseases, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial Details