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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

Overview

About this study

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences 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 CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. ≥ 18 years old.
  2. Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
  3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
  4. 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 (<3 unformed/loose stools/day) while taking this course of antibiotics]

Exclusion Criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
  2. Previous fecal transplant
  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  5. Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
  6. An absolute neutrophil count of <1000 cells/µL during screening.
  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sahil Khanna, M.B.B.S., M.S.

Closed for enrollment

More information

Publications

  • Clostridium difficile infection (CDI) continues to be a frequent and potentially severe infection. There is currently no validated clinical tool for use at the time of CDI diagnosis to categorize patients in order to predict response to therapy. Read More on PubMed

More about research at Mayo Clinic

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CLS-20382993

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