Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
|ClinicalTrials.gov Identifier: NCT02589847|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2015
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: RBX2660||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2018|
Experimental: open label
RBX2660 (microbiota suspention)
suspension of intestinal microbes
- Assess Efficacy As The Absence Of CDI Diarrhea Without The Need For Retreatment With C. difficile Anti-infective Therapy Or Fecal Transplant Through 56 days After Completion Of Study Treatment With RBX2660. [ Time Frame: 8 weeks after treatment ]Subjects will return 8 weeks after study treatment to assess efficacy of RBX2660.
- Number Of Subjects With Adverse Events Through 12 months [ Time Frame: 12 months after treatment ]The number of subjects with adverse events will be calculated through 12 months after study treatment with RBX2660; event frequency, severity, and relatedness will be assessed.
- Number of Subjects With Serious Adverse Events Through 24 Months [ Time Frame: 24 months after treatment ]The number of subjects with serious adverse events will be calculated through 24 months after study treatment; serious adverse event frequency, severity, and relatedness will be assessed through 24 months after completion treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589847
Show 30 Study Locations
|Study Chair:||Arnab Ray, MD||Ochsner Health System|