Rebiotix Inc, a Ferring company, is seeking investigators with clinical research experience and interest in C. difficile infection to participate in a Phase 3 Open-Label Safety and Tolerability Study.

Rebiotix is seeking clinical investigators with interest in C. difficile infection and other microbiome-related clinical research. To help us better understand your interest in clinical trial participation, please provide the following information:

    I have clinical research experience and am interested in recurrent C. difficile study participationI am interested in other microbiome-related clinical researchOther (provide additional information below)

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    Fecal Transplant Therapy Clinical Trial Now Enrolling
    Fecal Transplant Therapy Clinical Trial Now Enrolling

    Study Title

    A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection.

    Study Purpose

    The primary objective is to evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI.

    Study Treatment

    Study treatment consists of a single study enema of RBX2660. Study subjects who are deemed treatment failures may elect to receive another enema of RBX2660. There is no placebo drug given as part of this study.

    Study Follow-Up

    Follow-up includes in-office visits at weeks 1 and 8 after receiving RBX2660, and follow-up phone calls through 6 months.

    Key Study Inclusion Criteria*

    • ≥ 18 years old
    • Medical record documentation of either:
      • a) a current diagnosis or history of recurrent CDI as determined by the treating physician
      • b) or has had at least two episodes of severe CDI resulting in hospitalization
    • Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment
      • Note: Subject’s CDI diarrhea must be controlled while taking antibiotics during screening
    • Willing and able to provide informed consent and meet all study requirements
    Fecal Transplant Therapy Clinical Trial Now Enrolling
    Fecal Transplant Therapy Clinical Trial Now Enrolling

    Key Study Exclusion Criteria*

    • Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment
    • Fecal microbiota transplant (FMT) within the past 6 months
    • An absolute neutrophil count of <1000 cells/μL during screening
    • Pregnant, breastfeeding, or intends to become pregnant during study participation
    • Requires systemic antibiotic therapy for a condition other than CDI
    • Disease symptoms (e.g. diarrhea) caused by a confirmed intestinal pathogen other than C. difficile

    * Complete inclusion/exclusion criteria listing can be found in the Investigator's Brochure.

    Fecal Transplant Therapy Clinical Trial Now Enrolling

    Investigational Product

    RBX2660 is a broad spectrum, microbiota suspension prepared from thoroughly screened healthy human donors and is administered to subjects by enema.

    RBX2660 has previously been studied in three Phase 2 regulated clinical trials and has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA.

    Further information is available at ClinicalTrials.gov/ (NCT03931941)


    About the Sponsor

    Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases.

    Rebiotix

    Rebiotix Inc
    2660 Patton Road
    Roseville, MN 55113