5003598907S
AS A CO-INVESTIGATOR, DR. ALAN WOLFE WILL BE RESPONSIBLE FOR ALL ASPECTS OF AIM 1, AS WELL AS THE MICROBIAL DETECTION METHODS IN AIMS 2 AND 3. AS A BACTERIAL PHYSIOLOGIST, DR. WOLFE HAS THE EXPERTISE AND EXPERIENCE TO IDENTIFY THE REQUIREMENTS FOR SUCCESSFUL COLONIZATION OF LGG. AS THE FORMER DIRECTOR OF THE LOYOLA BIOMEDICAL INFORMATICS CORE AND OF THE LOYOLA GENOMICS FACILITY, DR. WOLFE HAS THE EXPERTISE AND EXPERIENCE TO OBTAIN AND ANALYZE MICROBIAL DATA (BY DNA-DEPENDENT (PCR AND 16S RRNA GENE SEQUENCING) AND DNA-INDEPENDENT (ENHANCED CULTURE). IN AIM 2, HIS TEAM ANALYZE THE URINARY MICROBIOME OF A MOUSE MODEL OF NLUTD TREATED INTRAVESICALLY WITH GENT-LGG. IN AIM 3, DR. WOLFE WILL ANALYZE URINARY ISOLATES OF PARTICIPANTS TREATED INTRAVESICALLY WITH GENT-LGG. FOR ALL 3 AIMS, DR. WOLFE WILL PARTICIPATE IN EXPERIMENTAL DESIGN, PERFORM ANALYSES, INTERPRET RESULTS, AND PREPARE MANUSCRIPTS. AS SITE BIOSTATISTICIAN, DR. CARA JOYCE WILL PROVIDE DATA CURATION AND ANALYSIS SUPPORT FOR MICROBIOME DATA ANALYZED BY DR. WOLFEÂ S LAB. SHE WILL DEVELOP DATA COLLECTION INSTRUMENTS EMPLOYING VALIDATION TO ENSURE DATA QUALITY. SHE WILL ALSO COLLABORATE CLOSELY WITH SENIOR BIOSTATISTICIAN AND TRANSLATIONAL SCIENTIST DR. ROCHELLE TRACTENBERG ON THE DESIGN AND ANALYSIS OF THE PILOT CLINICAL TRIAL (AIM 3), AS WELL AS PROVIDE CONSULTATIVE SUPPORT AND OVERSIGHT FOR STATISTICAL ANALYSES FOR AIMS 1-2. FOR AIM 3, DR. JOYCE WILL DEVELOP THE RANDOMIZATION AND DESIGN THE STUDY DATABASE IN RESEARCH ELECTRONIC DATA CAPTURE (REDCAP), A SECURE, WEB-BASED APPLICATION DESIGNED TO SUPPORT DATA CAPTURE FOR RESEARCH STUDIES. FOLLOWING COMPLETION OF THE TRIAL AND AFTER ALL FOLLOW-UP DATA ARE COLLECTED, DR. JOYCE WILL PERFORM STATISTICAL MODELING TO ANALYZE PRIMARY AND SECONDARY ENDPOINTS FOR MANUSCRIPT PREPARATION AND REPORTING TO CLINICALTRIALS.GOV. FOR ALL AIMS, DR. JOYCE WILL CONSULT ON DESIGN AND STATISTICAL METHODOLOGY, PERFORM ANALYSIS, AND FACILITATE DISSEMINATION OF RESULTS MARK KHEMANNI, AN EXPERIENCED MICROBIOME SCIENTIST, WILL BE RESPONSIBLE FOR SAMPLE RECEIPT, INVENTORY AND PREPARATION SAMPLES FOR PCR, 16S SEQUENCING AND FOR EQUC, THE ENHANCED CULTURE METHOD (AIMS 2 & 3). DR. MOHAMMAD KHAN HAS 6 YEARS POST-DOCTORAL EXPERIENCE IN MICROBIOME RESEARCH. HE WILL BE RESPONSIBLE FOR ALL ASPECTS OF AIM 1. THIS WORK WILL BE PERFORMED UNDER THE SUPERVISION OF DR. WOLFE.
Loyola University Of Chicago
Project Grant HT94252410372
$115.9k 9/1/24 5003596884S
DR. TRACTENBERG WILL SERVE AS THE SITE PI FOR GEORGETOWN UNIVERSITY, AS A CO INVESTIGATOR, AND AS THE DIRECTOR OF SCIENTIFIC, ANALYTIC, AND DATA TRANSLATION. SHE HAS WORKED WITH THE PI (GROAH) EXTENSIVELY ON ANALYTIC AND DATA TRANSLATION ACROSS CLINICAL TRIALS TO ENSURE THAT METHODOLOGICAL WORK IS INFORMATIVE FOR ANIMAL (BACK TRANSLATION) AS WELL AS PUBLIC HEALTH (FORWARD TRANSLATION). SHE HAS ALSO WORKED WITH CO-I FORSTER TO ENSURE THAT CLINICAL TRIAL INSTRUMENTS AND OUTCOMES DEVELOPED WITH PI GROAH HAVE ANALOGS IN ANIMAL MODELS FOR NEUROGENIC BLADDER AND UTI. THE PROPOSAL HAS BEEN CRAFTED BASED ON DR. TRACTENBERG'S MODEL FOR TRANSLATIONAL SCIENCE, WHICH FEATURES FORWARD, BACKWARD, AND LATERAL TRANSLATION. IN HER ROLE AS DIRECTOR OF SCIENTIFIC, ANALYTIC, AND DATA TRANSLATION, SHE HAS DESIGNED THE PILOT CLINICAL TRIAL (AIM 3), AND WORKED WITH THE OTHER CO-INVESTIGATORS (WOLFE, FOSTER) TO ENSURE THAT THE DESIGN OF THEIR AIMS AND METHODS WILL RESULT IN ACTIONABLY TRANSLATABLE OUTCOMES. AS THE SENIOR BIOSTATISTICIAN, SHE WILL ALSO SUPPORT THE DATA ANALYSES FROM ALL THREE AIMS (BENCH, PRE-CLINICAL, AND CLINICAL) WHICH WILL BE CARRIED OUT BY THE STUDY STATISTICIAN. DR. TRACTENBERG WILL WRITE AND/OR CONTRIBUTE TO PAPERS, POSTERS, AND PRESENTATIONS DISCUSSING THE TRANSLATIONAL ASPECTS OF THE PROJECT, INCLUDING METHODOLOGICAL INNOVATIONS. DR. TRACTENBERG WILL BE RESPONSIBLE FOR, OR CONTRIBUTE TO, THE SCHOLARLY WRITE UPS AND DISSEMINATION OF WORK FROM ALL AIMS AS WELL AS THE TRANSLATIONAL SCIENCE DIMENSIONS OF THE PROJECT.
Georgetown University
Project Grant HT94252410372
$19.5k 9/1/24 5003597347S
MAJOR TASK 2: DETERMINE THE OPTIMAL PERIOD BETWEEN GENTAMICIN AND LGG ADMINISTRATION TO OPTIMIZE BLADDER COLONIZATION. (SA 2) SUBTASK 1: CONFIRM THE UROBIOME OF MICE WITH SPINAL CORD INJURY. 1-8 CF SUBTASK 2: DETERMINE THE OPTIMAL WASHOUT PERIOD BETWEEN INTRAVESICAL GENTAMICIN AND LACTOBACILLUS RHAMNOSUS (LGG) 8-24 CF SUBTASK 3: ASSESS FOR SUCCESSFUL BLADDER COLONIZATION OF MOUSE BLADDERS BY LGG 8-24 CF MAJOR TASK 3: DETERMINE IN MEN AND IN WOMEN WITH SCI/D AND NLUTD: WHETHER TIMING (AIM 1) AND DOSING (AIM 2) AFFECT SUCCESS OF COLONIZATION; AND WHETHER COLONIZATION LASTS 7, 14, OR 28 DAYS; SAFETY (AE/SAE COUNTS) OF COUPLED INTRAVESICAL GENT-LGG. (SA3) SUBTASK 1: ADMINISTER INTRAVESICAL GENTAMICIN AND LGG TO PARTICIPANTS ENROLLED IN THE GREATER PITTSBURGH AREA 1-36 CF
University Of Pittsburgh - Of The Commonwealth System Of Higher Education
Project Grant HT94252410372
$125.3k 9/1/24