Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

Overview

About this study

The purpose of this tiral is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with Vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

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:

  • Is able to provide written informed consent.
  • Is a solid organ transplant (SOT) recipient.
  • Has had at recurrent C. difficile infection defined as:
    • Positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 60 day period following completion of treatment for prior episode;
    • No more than 3 CDI recurrences.
  • Negative pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment.
  • Clinical response to 4-7 days of oral antibiotic standard of care treatment for the current episode of CDI. Clinical response is defined as greater than 25% reduction of diarrhea.

Exclusion Criteria:

  • Has a history of chronic or active intestinal disease (e.g., Crohn's disease, ulcerative colitis).
  • Is unable to complete a daily stool diary (mental incapacity, head trauma, etc.).
  • Has presence of toxic megacolon or ileus.
  • Has presence of colostomy.
  • Is enrolled in another investigational drug trial.
  • Is severely immunocompromised (e.g., neutropenia, ≤ 500 neutrophils/ml [as noted in medical records and results within 6 months of Visit 1]).
  • Is unavailable for follow-up visits.
  • Is taking concomitant antibiotics at time of enrollment for anything other than for treatment of current CDI.
  • Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are not prohibited.
  • Has received an investigational product or been treated with an investigational device within 30 days prior to visit #1.
  • Co-infection with another intestinal pathogen.
  • Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Contact us for the latest status

Contact information:

Mary Glatzmaier RPSGT

(507) 284-9709

Glatzmaier.Mary@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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