Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
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|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|
|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.
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): NCT02589847
Show 30 Study Locations
|Study Chair:||Arnab Ray, MD||Ochsner Health System|