Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

Recurrent Clostridium Difficile Infection Clinical Trial

— PUNCH CD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925417
• Other study ID #: 2013-001
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2018
• Source: Rebiotix Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Description:

This is the first study of a microbiota suspension derived from intestinal microbes. The primary assessments for this open label, multi-center study are (i) occurrence of product-related adverse events and (ii) resolution of CDAD at 56 days after administration of RBX2660. Subjects will also be assessed for time to CDAD recurrence, quality of life changes, and number of hospitalizations and length of stay for recurrent CDAD. Study visits will be at 7, 30, and 60 days after RBX2660 administration with additional follow-up at 3 and 6 months post treatment. Patients who have had at least two recurrences of CDAD after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDAD resulting in hospitalization may be eligible for the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Clostridium Infections
• Diarrhea
• Recurrent Clostridium Difficile Infection

Intervention

Biological:
• RBX2660 (microbiota suspension)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Edward Hines Jr VA Hospital (veterans only)	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Denver Health and University of Colorado	Denver	Colorado
United States	Detroit Medical Center	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Sanford Research/USD	Fargo	North Dakota
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic - Minnesota	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Rebiotix Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660	Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.	56 days
Secondary	Long-term Safety	The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.	6 months
Secondary	Absence of CDAD at 56 Days	Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.	56 days
Secondary	Quality of Life (SF-36)	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.	60 days
Secondary	Post-treatment Hospitalization Data	number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.	6 months