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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01925417
Other study ID # 2013-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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