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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.
ClinicalTrials.gov Identifier:
NCT01925417
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: Endpoint Classification: Safety Study;   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
  Description
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)  
STARTED     34  
COMPLETED     31  
NOT COMPLETED     3  
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
  Description
RBX2660 (Microbiota Suspension) Open-label; all subjects received RBX2660

Baseline Measures
    RBX2660 (Microbiota Suspension)  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     21  
Age  
[units: years]
Mean (Full Range)
  66.8  
  (26.7 to 89.6)  
Gender  
[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.   Safety Issue:   No


  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
e-mail: mksobcinski@rebiotix.com


Publications:

Responsible Party: Rebiotix Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration