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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)

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: NCT02299570
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : July 27, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Enterocolitis Clostridium Difficile Recurrent
Interventions Biological: RBX2660 (microbiota suspension)
Other: Placebo
Enrollment 150
Recruitment Details Recruitment was from 12/10/14 to 11/13/15 at 21 medical clinics in the United States and Canada. Recruiment was performed by trained investigators and study coordinators.
Pre-assignment Details Seventeen enrolled subjects did not proceed to randomization and were exited from the study. Of the 133 randomized subjects remaining, five subjects chose to withdraw prior to treatment and in one subject the first blinded enema was not able to be initiated due to anxiety and the subject subsequently chose to withdraw.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Period Title: Overall Study
Started 45 44 44
Completed 41 44 42
Not Completed 4 0 2
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Total of all reporting groups
Overall Number of Baseline Participants 45 44 44 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  42.2%
25
  56.8%
26
  59.1%
70
  52.6%
>=65 years
26
  57.8%
19
  43.2%
18
  40.9%
63
  47.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 44 participants 133 participants
63.6  (19.15) 58.8  (19.24) 61.0  (19.69) 61.1  (19.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
Female
26
  57.8%
30
  68.2%
25
  56.8%
81
  60.9%
Male
19
  42.2%
14
  31.8%
19
  43.2%
52
  39.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
Hispanic or Latino
1
   2.2%
2
   4.5%
1
   2.3%
4
   3.0%
Not Hispanic or Latino
43
  95.6%
42
  95.5%
42
  95.5%
127
  95.5%
Unknown or Not Reported
1
   2.2%
0
   0.0%
1
   2.3%
2
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.3%
2
   4.5%
3
   2.3%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
44
  97.8%
43
  97.7%
42
  95.5%
129
  97.0%
More than one race
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 44 participants 133 participants
Canada 12 8 8 28
United States 33 36 36 105
1.Primary Outcome
Title Efficacy of Active Treatment Compared to Placebo at Measured at 8 Weeks Post-treatment
Hide Description The absence of C. difficile diarrhea without the need for retreatment at 56 days after administration of the last assigned study enema, will be compared between the number of subjects who receive two enemas of RBX2660 to the number of subjects who receive two enemas of placebo.
Time Frame 8 weeks after last assigned study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Two enemas of RBX2660 (microbiota suspension) administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

Overall Number of Participants Analyzed 41 44 42
Measure Type: Count of Participants
Unit of Measure: Participants
25
  61.0%
20
  45.5%
28
  66.7%
2.Secondary Outcome
Title Number of Subjects With Adverse Events Through 12 Months
Hide Description The number of subjects in each treatment group with adverse events will be calculated through 12 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.
Time Frame 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Subjects With Serious Adverse Events Through 24 Months
Hide Description The number of subjects in each treatment group with serious adverse events will be calculated through 24 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.
Time Frame 24 months after last treatment with RBX2660
Outcome Measure Data Not Reported
Time Frame Adverse events reported are those available as part of the interim analysis conducted when the last subject completed 8 weeks post-blinded enema. Final adverse events will be reported by January 2019 when final analysis has been completed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Two enemas of RBX2660 administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Two enemas of placebo administered 7 days apart

Placebo: A suspension of saline and cryoprotectant

1 enema of RBX2660 and 1 enema of placebo administered 7 days apart

RBX2660 (microbiota suspension): A suspension of intestinal microbes

Placebo: A suspension of saline and cryoprotectant

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/41 (7.32%)      0/44 (0.00%)      3/43 (6.98%)    
Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/41 (31.71%)      6/44 (13.64%)      7/43 (16.28%)    
Blood and lymphatic system disorders       
Anaemia   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
LEUKOCYTOSIS   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Cardiac disorders       
Cardiac failure congestive   1/41 (2.44%)  1 0/44 (0.00%)  0 1/43 (2.33%)  1
Congenital, familial and genetic disorders       
Arnold-Chiari malformation   0/41 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain   1/41 (2.44%)  1 0/44 (0.00%)  0 2/43 (4.65%)  2
CONSTIPATION   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Diarrhoea   0/41 (0.00%)  0 0/44 (0.00%)  0 2/43 (4.65%)  3
Gastrointestinal haemorrhage   0/41 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Intestinal obstruction   1/41 (2.44%)  1 1/44 (2.27%)  1 1/43 (2.33%)  2
Nausea   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Hepatobiliary disorders       
Cholelithiasis   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Infections and infestations       
Osteomyelitis chronic   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Pneumonia   0/41 (0.00%)  0 1/44 (2.27%)  1 1/43 (2.33%)  1
SEPSIS   1/41 (2.44%)  1 0/44 (0.00%)  0 1/43 (2.33%)  1
Urinary Tract Infection   1/41 (2.44%)  1 1/44 (2.27%)  1 1/43 (2.33%)  1
Influenza   0/41 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Injury, poisoning and procedural complications       
Periorbital haematoma   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Gastrointestinal anastomotic leak   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Metabolism and nutrition disorders       
DEHYDRATION   0/41 (0.00%)  0 1/44 (2.27%)  2 0/43 (0.00%)  0
HYPONAETREMIA   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ADENOCARCINOMA   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Small cell carcinoma   0/41 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Nervous system disorders       
PARKINSONISM   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Pregnancy, puerperium and perinatal conditions       
Ruptured ectopic pregnancy   0/41 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Psychiatric disorders       
Mental status changes   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Renal and urinary disorders       
NEPHROLITHIASIS   1/41 (2.44%)  1 1/44 (2.27%)  1 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Respiratory failure   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Skin and subcutaneous tissue disorders       
Skin ulcer   0/41 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Surgical and medical procedures       
Leg amputation   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Ureteral stent insertion   1/41 (2.44%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/41 (43.90%)      19/44 (43.18%)      13/43 (30.23%)    
Gastrointestinal disorders       
Abdominal distension   4/41 (9.76%)  6 6/44 (13.64%)  11 3/43 (6.98%)  3
Abdominal Pain   11/41 (26.83%)  18 10/44 (22.73%)  19 9/43 (20.93%)  11
anorectal discomfort   4/41 (9.76%)  7 8/44 (18.18%)  10 2/43 (4.65%)  3
Diarrhoea   13/41 (31.71%)  21 9/44 (20.45%)  12 3/43 (6.98%)  7
General disorders       
Pyrexia   2/41 (4.88%)  2 4/44 (9.09%)  5 7/43 (16.28%)  10
Indicates events were collected by systematic assessment
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: Assoc. Director of Clinical Research
Organization: Rebiotix
Phone: 651-705-8778
EMail: smische@rebiotix.com
Layout table for additonal information
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT02299570    
Other Study ID Numbers: 2014-01
First Submitted: November 19, 2014
First Posted: November 24, 2014
Results First Submitted: July 2, 2018
Results First Posted: July 27, 2018
Last Update Posted: October 5, 2018