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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.
 
ClinicalTrials.gov Identifier: NCT01925417
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : July 1, 2015
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Clostridium Difficile Infection
Intervention Biological: RBX2660 (microbiota suspension)
Enrollment 34
Recruitment Details 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  
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Period Title: Overall Study
Started 34
Completed 31
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Death             1
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description Open-label; all subjects received RBX2660
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  38.2%
>=65 years
21
  61.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
66.8
(26.7 to 89.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
23
  67.6%
Male
11
  32.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Hispanic or Latino
1
   2.9%
Not Hispanic or Latino
33
  97.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Hide Description Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
31 subjects had evaluable data at 56 days.
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description:
This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: number of reported SAEs through 56 days
10
2.Secondary Outcome
Title Long-term Safety
Hide Description The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
31 subjects had evaluable data at 6 months.
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description:
This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: number of reported SAEs
20
3.Secondary Outcome
Title Absence of CDAD at 56 Days
Hide Description Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
31 subjects had evaluable data at 56 days.
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description:
This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants with treatment success
27
4.Secondary Outcome
Title Quality of Life (SF-36)
Hide Description

Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.

The scale is from 0-100, with higher scores meaning better outcomes.

Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description:
RBX2660 (microbiota suspension) enema-based delivery
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 42.2  (14.6)
7-Day 47.7  (11.7)
30-DAy 48.6  (11.8)
60-Day 51.3  (11.2)
5.Secondary Outcome
Title Post-treatment Hospitalization Data
Hide Description number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
31 subjects had evaluable data at 6 months.
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description:
This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Number of Participants Analyzed 31
Median (Full Range)
Unit of Measure: number of particpants' ICU days
0
(0 to 0)
Time Frame From time of enrollment through the 6-month follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RBX2660 (Microbiota Suspension)
Hide Arm/Group Description This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
All-Cause Mortality
RBX2660 (Microbiota Suspension)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RBX2660 (Microbiota Suspension)
Affected / at Risk (%) # Events
Total   7/34 (20.59%)    
General disorders   
Non-cardiac Chest Pain * 1  1/34 (2.94%)  1
Infections and infestations   
Clostridium difficile infection * 1  3/34 (8.82%)  4
Urinary Tract Infection * 1  1/34 (2.94%)  1
Pneumonia * 1  1/34 (2.94%)  1
Clostridium difficile Colitis * 1  1/34 (2.94%)  3
Bacteraemia * 1  1/34 (2.94%)  1
Injury, poisoning and procedural complications   
Pelvic Fracture * 1  1/34 (2.94%)  1
Stab Wound * 1  1/34 (2.94%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Adenocarcinoma * 1  1/34 (2.94%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure * 1  1/34 (2.94%)  1
Chronic Obstructive Pulmonary Disease * 1  1/34 (2.94%)  1
Pulmonary Oedema * 1  1/34 (2.94%)  1
Hypoxia * 1  1/34 (2.94%)  1
Pneumothorax * 1  1/34 (2.94%)  1
Surgical and medical procedures   
Chemotherapy * 1  1/34 (2.94%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
RBX2660 (Microbiota Suspension)
Affected / at Risk (%) # Events
Total   23/34 (67.65%)    
Gastrointestinal disorders   
Abdominal Distension  1 [1]  7/34 (20.59%)  9
Abdominal Pain  1  10/34 (29.41%)  14
Anorectal Discomfort  1  5/34 (14.71%)  6
Constipation  1  8/34 (23.53%)  14
Diarrhoea  1  10/34 (29.41%)  26
Flatulence  1  13/34 (38.24%)  15
Nausea  1  5/34 (14.71%)  5
Proctalgia  1  2/34 (5.88%)  3
Vomiting  1  4/34 (11.76%)  5
General disorders   
Chills  1  5/34 (14.71%)  5
Fatigue * 1  3/34 (8.82%)  3
Pyrexia  1  4/34 (11.76%)  4
Infections and infestations   
Nasopharyngitis * 1  2/34 (5.88%)  2
Upper Respiratory Tract Infection * 1  2/34 (5.88%)  3
Urinary Tract Infection * 1  2/34 (5.88%)  2
Metabolism and nutrition disorders   
Dehydration * 1  2/34 (5.88%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/34 (5.88%)  2
Nervous system disorders   
Headach * 1  2/34 (5.88%)  3
Anxiety * 1  2/34 (5.88%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
[1]
Most were mild-moderate in severity and resolved within 7 days of receiving RBX2660.
Small sample size (n=34) limits extrapolation of results to a larger population.
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
Layout table for Results Point of Contact information
Name/Title: Sarah Mische PhD, Associate Director of Clinical Research
Organization: Rebiotix
Phone: 6512122839
EMail: smische@rebiotix.com
Layout table for additonal information
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT01925417    
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: November 13, 2019