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Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic Resistant Bacteria

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Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic Resistant Bacteria RACE: Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria ClinicalTrials.gov Identifier: NCT03061097 RACE Study 1 Version 5.0 Version Date 17 Sept 2019 Statement of Compliance The study will be carried out in accordance with Good Clinical Practices (GCP) as required by the following: 1. United States Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46; 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, and 21 CFR Part 312); 2. International Conference on Harmonization (ICH) E6; 62 Federal Register 25691 (1997); Compliance with these standards provides public assurance that the rights, safety and well-being of study subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. All key personnel (all individuals responsible for the design and conduct of this study) have completed Human Subjects Protection Training. RACE Study 2 Version 5.0 Version Date 17 Sept 2019 PRINCIPAL CLINICIAN SIGNATURE PAGE Protocol Title: Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria Version Date: 17 September 2019 I acknowledge that I have read and understand the protocol named above and agree to conduct the study according to the protocol named above. I also agree and will adhere to terms and procedures in accordance with United States Food and Drug Administration (FDA)/International Council for Harmonisation (ICH) guidelines, including all federal and locally applicable regulations and laws. I assure that the study drug supplied by OpenBiome will be used only as described in the protocol named above. ____________________________________________ _________________________ Signature Date ____________________________________________ Print Name RACE Study 3 Version 5.0 Version Date 17 Sept 2019 APPENDIX C: TABLE OF CONTENTS Statement of Compliance ....................................................................................................... 2 C.1. List of Abbreviations ......................................................................................................... 8 C.2. Protocol Summary .......................................................................................................... 10 C.3. Key Roles ........................................................................................................................ 13 C.4. Background Information and Scientific Rationale ...................................................... 15 C.4.1. Background Information .............................................................................................15 C.4.1.1 Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium difficile Infection and Other ARB ............................................................15 C.4.1.2. Rationale ........................................................................................................17 C.4.1.3. Potential Impact ............................................................................................17 C.4.2 Potential Risks and Benefits ..........................................................................................17 C.4.2.1. Potential Risks .................................................................................................17 C.4.2.2. Insufficient Enrollment Risk .............................................................................18 C.4.2.3. Safety Risks .....................................................................................................18 C.4.2.4. Baseline Geriatric Microbiome Risk ..............................................................19 C.4.2.5. Known Potential Benefits...............................................................................19 C.5. Objectives ...................................................................................................................... 20 C.5.1 Study Objective ............................................................................................................20 C.5.1.1. Study Objective .............................................................................................20 C.5.1.2. Primary Objectives.........................................................................................20 C.5.1.3. Secondary Objectives ..................................................................................20 C.5.2. Endpoints ......................................................................................................................20 C.5.2.1. Primary Endpoint ............................................................................................20 C.5.2.2. Secondary Endpoints ....................................................................................20 C.5.2.3. Possible Exploratory Endpoints ......................................................................21 C.6. Study Design ................................................................................................................... 22 C.6.1. Study Population ..........................................................................................................22 C.6.2. Intervention...................................................................................................................22 C.6.2.1. Dosing Rationale ...........................................................................................22 C.6.3. Control ..........................................................................................................................22 C.7. Inclusion and Exclusion Criteria .................................................................................... 23 C.7.1. Inclusion Criteria ...........................................................................................................23 C.7.1.1. Inclusion Criteria for Study Enrollment ..........................................................23 C.7.1.2. Inclusion Criteria for Randomization ............................................................23 C.7.2. Exclusion Criteria ..........................................................................................................23 C.7.2.1. Exclusion Criteria for Study Enrollment .........................................................23 C.7.2.2. Exclusion Criteria for Stool Collection ...........................................................23 C.7.2.3. Exclusion Criteria for Randomization ............................................................24 C.8. Treatment Assignment Procedures ............................................................................... 25 C.8.1. Randomization Procedures .........................................................................................25 RACE Study 4 Version 5.0 Version Date 17 Sept 2019 C.8.2. Masking Procedure ......................................................................................................25 C.8.3. Interim Analysis .............................................................................................................25 C.8.4. Participant Withdrawal ................................................................................................26 C.8.5. Procedure for Handling Participant Withdrawal .......................................................26 C.8.6. Study Termination .........................................................................................................26 C.9. Study Interventions / Investigational Drug ................................................................... 27 C.9.1. Interventional Product Description .............................................................................27 C.9.1.1. Autologous Treatment Preparation .............................................................27 C.9.1.2. Fecal Microbiota Transplant (FMT) ...............................................................27 C.9.2. Formulation ...................................................................................................................27 C.9.2.1. Auto-FMP Enema ...........................................................................................27 C.9.2.2. Placebo Enema Preparation ........................................................................27 C.9.3. Product Storage and Stability .....................................................................................27 C.9.3.1. Auto-FMP Enema Preparation ......................................................................27 C.9.4. Dosage, Preparation and Administration of Study Intervention ..............................28 C.9.4.1. Auto-FMP Enema ...........................................................................................28 C.9.5. Accountability Procedures for the Study Intervention/Investigational Product(s) .28 C.9.6. Assessment of Participant Compliance with Study Intervention/Investigational Product ....................................................................................................................................28 C.9.7. Concomitant Medications/Treatments......................................................................28 C.9.8. Screening Visit and Patient Information (Visit 1) ........................................................29 C.9.9. Collection and Processing (Visit 2) .............................................................................30 C.9.10. Surveillance for Infectious Episodes ..........................................................................30
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