Lactobacillus intravescicale per ridurre i sintomi urinari dopo una lesione del midollo spinale
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
2 urine samples (sampling at least 2 weeks apart) for urinalysis, urine culture, uNGAL, and NGS (16S rRNA and shotgun) under the same conditions. In addition to completing the USQNB-IC prior to urine collection, participants will complete the USQNB-IC 3 days after urine collection
SPECIFIC AIM 2 Intravesical LGG dose (group: high or low) will be obtained, USQNB-IC, urine collection for urinalysis, culture, NGAL and next generation sequencing as described above. And patient satisfaction questions.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20010
- MedStar National Rehabilitation Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- SCI at least 1-year duration;
- Neurogenic bladder;
- Utilizing intermittent catheterization for bladder management;
- Women must be premenopausal and not currently menstruating;
- Community dwelling
Exclusion Criteria:
- Use of prophylactic antibiotics;
- Instillation of intravesical antimicrobials to prevent UTI;
- Psychologic or psychiatric conditions influencing the ability to follow instructions;
- Use of oral or IV antibiotics within the past 2 weeks;
- Sexual activity within the previous 72 hours;
- Participation in another study with which results could be confounded.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Low Dosage Group
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. Participants will receive 2 LGG capsules and will repeat this process the following day ("Low" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion. |
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night ("Low" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules
Altri nomi:
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Sperimentale: High Dosage Group
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. Participants will receive 4 LGG capsules and will repeat this process the following day twice for a total of four doses ("High" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion. |
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily for a total of four doses ("High" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Successful Reduction of Urinary Symptoms
Lasso di tempo: Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.
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20% reduction in urinary symptoms within 48 hours of completion of intervention |
Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Leukocyte Esterase
Lasso di tempo: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 36 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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urinary leukocyte esterase level (ordinal count levels) |
Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 36 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Change in Cultivable Bacteria Pre and Post LGG Instillations
Lasso di tempo: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Standard urine culture (SUC) results based on quantity (colony forming units) and identified organism. (number of organisms cultivated/identified; yes/no if any were cultivated at or greater than 10^5) |
Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Change in Urine Nitrite Pre and Post LGG Instillations
Lasso di tempo: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Standard urine analysis. Urine derived nitrites (positive or negative) |
Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Change in Urine White Blood Cell Count Pre and Post LGG Instillations
Lasso di tempo: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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urine derived white blood cells per high powered field (ordinal count levels) |
Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Change in uNGAL Pre and Post LGG Instillations
Lasso di tempo: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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urinary neutrophil gelatinase-associated lipocalin in µg/L (continuous) |
Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Suzanne Groah, MD, MSPH, MedStar National Rehabilitation Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Manifestazioni neurologiche
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Ferite e lesioni
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Trauma, sistema nervoso
- Malattie della vescica urinaria
- Malattie del midollo spinale
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Lesioni del midollo spinale
- Vescica urinaria, neurogena
Altri numeri di identificazione dello studio
- STUDY00001124
- CDMRP-eBRAP Log Number (Altro identificatore: CDMRP-SC180210)
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