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

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. Read our disclaimer for details. Identifier: NCT01925417
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : July 1, 2015
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Rebiotix Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Clostridium Difficile Infection
Intervention: Biological: RBX2660 (microbiota suspension)

  Participant Flow

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

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]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      13  38.2% 
>=65 years      21  61.8% 
[Units: Years]
Mean (Full Range)
 (26.7 to 89.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      23  67.6% 
Male      11  32.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      1   2.9% 
Not Hispanic or Latino      33  97.1% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   34 

  Outcome Measures

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

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

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
First Submitted: August 15, 2013
First Posted: August 19, 2013
Results First Submitted: May 28, 2015
Results First Posted: July 1, 2015
Last Update Posted: May 30, 2017