Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

NCT01925417 | Completed Phase 2 Results

• 1 other identifier: 2013-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Recurrent Clostridium Difficile Infection

Keywords

Clostridium difficile; C diff; Microbiota Restoration Therapy; MRT; microbiota suspension; CDI; CDAD; Fecal transplant; Fecal Microbiota Transplant; FMT; Diarrhea; Fecal bacteriotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Long-term Safety

  6 months

• Absence of CDAD at 56 Days

  56 days

• Quality of Life (SF-36)

  60 days

• Post-treatment Hospitalization Data

  6 months

Study Arms (1)

RBX2660 (microbiota suspension)

EXPERIMENTAL

enema-based delivery of RBX2660

Biological: RBX2660 (microbiota suspension)

Interventions

RBX2660 (microbiota suspension) BIOLOGICAL

RBX2660 (microbiota suspension)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rebiotix Inc.: lead

Study Sites (13)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Denver Health and University of Colorado

Denver, Colorado, 80204, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32216, United States

Location

Edward Hines Jr VA Hospital (veterans only)

Chicago, Illinois, 60141, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic - Minnesota

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Sanford Research/USD

Fargo, North Dakota, 58122, United States

Location

Related Publications (6)

• 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.

  PMID: 23323867 BACKGROUND

• 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.

  PMID: 22002980 BACKGROUND

• 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.

  PMID: 23152734 BACKGROUND

• Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Therap Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.

  PMID: 41245385 DERIVED

• 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.

  PMID: 33593430 DERIVED

• 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.

  PMID: 26565008 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size (n=34) limits extrapolation of results to a larger population.

Results Point of Contact

• Title: Sarah Mische PhD, Associate Director of Clinical Research
• Organization: Rebiotix

smische@rebiotix.com

6512122839

Study Officials

• Dimitri Drekonja, MD

  Veteran Administration Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 13, 2019
• Results First Posted: July 1, 2015

Record last verified: 2018-09

Locations

US (13)