Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03643887|
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: FMT Capsule DE Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomized, placebo controlled trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II Randomized, Double-blind Placebo-controlled Trial of Fecal Microbiota Transplantation for Vancomycin-resistant Enterococcus and Carbapenem-resistant Enterobacteriaceae|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: FMT Capsule DE
FMT Capsule DE
Drug: FMT Capsule DE
30 capsule one-time oral dose
Placebo Comparator: Placebo Oral Capsule
Drug: Placebo oral capsule
30 capsule one-time oral dose
Other Name: Placebo
- Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo [ Time Frame: 6 months ]VRE/CRE decolonization is defined by absence of VRE/CRE on stool culture using standard laboratory techniques.
- VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization. [ Time Frame: 1 month ]VRE/CRE infection will be defined as an associated bacteremia, urinary tract infection, or would-related infection.
- Microbial engraftment assessed by microbial disruption index (MDI) at Day 3, Day 10, and Week 4 following randomization [ Time Frame: 1 month ]VRE/CRE type and strain level engraftment, using whole genome sequencing laboratory techniques
- Antibiotic resistant bacteria (ARB) decolonization at Day 10 after randomization. [ Time Frame: 10 days ]ARB testing will be done with Acuitas (OpGen) MDRO test or a similar platform
- Antibiotic resistant bacteria (ARB) infection at Day 3, Day 10, Week 4 after randomization, and time to infection if ARB infection occurs [ Time Frame: 1 month ]ARB infection will be defined as extended spectrum beta lactamase clinical infection.
- Adverse events/serious adverse events through Day 10, Week 4, and Month 6 following randomization. [ Time Frame: 6 months ]Safety of FMT Capsule DE compared to placebo. Incidence of newly acquired transmissible infectious diseases that are considered adverse events of special interest (AESI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643887
|Contact: Michele L Zimbric, BSfirstname.lastname@example.org|
|Contact: Ashley M Kates, PhDemail@example.com|
|Principal Investigator:||Nasia Safdar, MD PhD||Infectious Disease, School of Medicine & Public Health, University of Wisconsin-Madison|