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

Overview

About this study

The purpose of this trial 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.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Ability to take oral medication.
  • Male or female, at least 18 years of age.
  • Is a solid organ transplant (SOT) recipient.
  • Has recurrent C. difficile infection. A C. difficile recurrence is defined as:
    •  Positive C. difficile testing in stool (confirmed via medial record review) AND
    •  Diarrhea (≥3 loose stools over 24 hours) during the 180-day period following completion of treatment for prior CDI episode.
  • History of positive IgG testing to cytomegalovirus (CMV) and Epstein Barr Virus (EBV) for subject.
  • Clinical response to 4-10 days of C. difficile treatment for the current CDI episode. Clinical response is defined as ≥5% reduction of diarrhea.
  • Females of childbearing potential must have a negative urine or serum pregnancy test at baseline and prior to randomization. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception.
    • Note: Acceptable method of contraception is defined as those, alone or in combination, that result in a low failure rate [i.e. less than 1% per year] or in conjunction with their sexual partner(s), use 2 forms of medically acceptable contraceptive methods that have a reported failure rate of >1% per year. Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.

 

Exclusion Criteria:

  • Major bowel resection surgery within 90 days of randomization.
  • Active chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis).
  • History of total colectomy or bariatric surgery.
  • Known or suspected toxic megacolon and/or known small bowel ileus.
  • Presence of colostomy or ileostomy.
  • Concomitant antibiotic use within 48 hours of Visit 2. Topical antibiotics and SOT prophylaxis (e.g., trimethoprim-sulfamethoxazole) are permitted.
  • Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS), or patient shows evidence of dysphagia when the ‘safety test’ capsule is administered.
  • Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT.
  • Active, severe gastroparesis
  • Unwilling to withhold probiotics for duration of study. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are permitted.
  • Neutropenia, ≤500 neutrophils/mL [abstracted from the medical record and resulted within 7 days of Visit 2].
  • Symptomatic co-infection with another intestinal pathogen as determined by chart review.
  • Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor.
  • Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions.
  • Expected life expectancy <6 months.
  • Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  • Women who are pregnant, lactating or planning on becoming pregnant during the study.
  • Not suitable for study participation due to other reasons at the discretion of the investigators        

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.

Open for enrollment

Contact information:

Rebecca Hofschulte CRCST

(507) 284-9709

Hofschulte.Rebecca@mayo.edu

More information

Publications

Publications are currently not available