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Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)

This study has been completed.
Information provided by (Responsible Party):
Rebiotix Inc. Identifier:
First received: August 15, 2013
Last updated: June 30, 2015
Last verified: June 2015
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Clostridium Difficile Infection
Intervention: Biological: RBX2660 (microbiota suspension)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was from 07/15/13 to 12/16/13 at 13 medical clinics in the United States. Recruiment was performed by trained investigators and study coordinators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
RBX2660 (Microbiota Suspension) This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).

Participant Flow:   Overall Study
    RBX2660 (Microbiota Suspension)
Withdrawal by Subject                2 
Death                1 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
RBX2660 (Microbiota Suspension) Open-label; all subjects received RBX2660

Baseline Measures
   RBX2660 (Microbiota Suspension) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   21 
[Units: Years]
Mean (Full Range)
 (26.7 to 89.6) 
[Units: Participants]
Female   23 
Male   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   1 
Not Hispanic or Latino   33 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
United States   34 

  Outcome Measures
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1.  Primary:   Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660   [ Time Frame: 56 days ]

2.  Secondary:   Long-term Safety   [ Time Frame: 6 months ]

3.  Secondary:   Absence of CDAD at 56 Days   [ Time Frame: 56 days ]

4.  Secondary:   Post-treatment Hospitalization Data   [ Time Frame: 6 months ]

5.  Secondary:   Quality of Life   [ Time Frame: 60 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size (n=34) limits extrapolation of results to a larger population.

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Mary Kay Sobcinski, Director of Clinical Operations
Organization: Rebiotix
phone: 6519644488

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Rebiotix Inc. Identifier: NCT01925417     History of Changes
Other Study ID Numbers: 2013-001
Study First Received: August 15, 2013
Results First Received: May 28, 2015
Last Updated: June 30, 2015