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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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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)
Arm/Group Description	This was an open-label, non-randomi...
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

Baseline Characteristics

Arm/Group Title		RBX2660 (Microbiota Suspension)
Arm/Group Description		Open-label; all subjects received R...
Arm/Group Description		Open-label; all subjects received RBX2660
Overall Number of Baseline Participants		34
Baseline Analysis Population Description		[Not Specified]
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
United States		34

Outcome Measures

1.Primary Outcome


Title	Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Description	Safety will be assessed by evaluating the incidence of serious adverse...
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

Outcome Measure Data

Analysis Population Description

31 subjects had evaluable data at 56 days.


Arm/Group Title	RBX2660 (Microbiota Suspension)
Arm/Group Description:	This was an open-label, non-randomi...
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
Description	The incidence of serious adverse events will be assessed through 6 mon...
Description	The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

31 subjects had evaluable data at 6 months.


Arm/Group Title	RBX2660 (Microbiota Suspension)
Arm/Group Description:	This was an open-label, non-randomi...
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
Description	Number of participants who were determined to be free of CDAD at Day 5...
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

Outcome Measure Data

Analysis Population Description

31 subjects had evaluable data at 56 days.


Arm/Group Title	RBX2660 (Microbiota Suspension)
Arm/Group Description:	This was an open-label, non-randomi...
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)
Description	Quality of Life (SF-36) will be assessed by comparing the subject's ba...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RBX2660 (Microbiota Suspension)
Arm/Group Description:	RBX2660 (microbiota suspension) ene...
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
Description	number of ICU days was collected for subjects who received RBX2660 and...
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

Outcome Measure Data

Analysis Population Description

31 subjects had evaluable data at 6 months.


Arm/Group Title	RBX2660 (Microbiota Suspension)
Arm/Group Description:	This was an open-label, non-randomi...
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)

Adverse Events

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)
Arm/Group Description	This was an open-label, non-randomi...
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	--/--
Serious Adverse Events 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)
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.

Limitations and Caveats

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

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

Publications:

van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

Rohlke F, Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 Nov;5(6):403-20. doi: 10.1177/1756283X12453637.

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

Langdon A, Schwartz DJ, Bulow C, Sun X, Hink T, Reske KA, Jones C, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study. Genome Med. 2021 Feb 16;13(1):28. doi: 10.1186/s13073-021-00843-9.

Orenstein R, Dubberke E, Hardi R, Ray A, Mullane K, Pardi DS, Ramesh MS; PUNCH CD Investigators. Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study. Clin Infect Dis. 2016 Mar 1;62(5):596-602. doi: 10.1093/cid/civ938. Epub 2015 Nov 12.

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