Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)
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|ClinicalTrials.gov Identifier: NCT01925417|
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : July 1, 2015
Last Update Posted : November 13, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Recurrent Clostridium Difficile Infection||Biological: RBX2660 (microbiota suspension)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||July 2014|
Experimental: RBX2660 (microbiota suspension)
enema-based delivery of RBX2660
Biological: RBX2660 (microbiota suspension)
- Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 [ Time Frame: 56 days ]Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
- Long-term Safety [ Time Frame: 6 months ]The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
- Absence of CDAD at 56 Days [ Time Frame: 56 days ]Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.
- Quality of Life (SF-36) [ Time Frame: 60 days ]
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.
- Post-treatment Hospitalization Data [ Time Frame: 6 months ]number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ≥ 18 years
- Medical record documentation of CDAD either: a) at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in hospitalization.
- Willing and able to have an enema(s).
- Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14 days, including at least seven days of oral vancomycin.
- Willing and able to complete the required subject diary.
- Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.
- Requires antibiotic therapy for a condition other than CDAD.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
- History of chronic diarrhea.
- History of celiac disease.
- History of cirrhosis of the liver or ascites.
- Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium difficile.
- Has a colostomy.
- Intraabdominal surgery within the last 60 days.
- Evidence of active, severe colitis.
- History of short gut syndrome or motility disorders.
- Requires the regular use of medications that affect bowel motility (e.g., metoclopramide, narcotics, loperamide).
- Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
- Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days after enrollment.
- Neutropenia (white blood cell count <1000 cells/µL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925417
|United States, Arizona|
|Mayo Clinic Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Colorado|
|Denver Health and University of Colorado|
|Denver, Colorado, United States, 80204|
|United States, Florida|
|Jacksonville, Florida, United States, 32216|
|United States, Illinois|
|Edward Hines Jr VA Hospital (veterans only)|
|Chicago, Illinois, United States, 60141|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Chevy Chase Clinical Research|
|Chevy Chase, Maryland, United States, 20815|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Detroit Medical Center|
|Detroit, Michigan, United States, 48201|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Mayo Clinic - Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, North Dakota|
|Fargo, North Dakota, United States, 58122|
|Study Chair:||Dimitri Drekonja, MD||Veteran Administration Medical Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Rebiotix Inc.|
|Other Study ID Numbers:||
|First Posted:||August 19, 2013 Key Record Dates|
|Results First Posted:||July 1, 2015|
|Last Update Posted:||November 13, 2019|
|Last Verified:||September 2018|
Microbiota Restoration Therapy
Fecal Microbiota Transplant
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses