Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea

Launched by BAYLOR COLLEGE OF MEDICINE · May 30, 2013

Keywords

ClinConnect Summary

This study will initially enroll 12 subjects. Based on the relatively large experience with FMT reported to date, we anticipate a prompt and sustained response as determined by a cessation of fever, leukocytosis and diarrhea and a loss of abdominal discomfort in \>8 (80%) of the subjects. If such a response is not observed in \>3 of the first 6 patients treated, we will reevaluate the composition of the FMT mixture and/or consider whether more than one inoculum should be given. If the 80% or greater success rate is achieved, clinical follow-up and studies of the microbiome will continue for...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (\>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin \<3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB.
• Exclusion Criteria:
• • Exclusion criteria include: treatment with major immunosuppressive agents including prednisone \>10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine \>4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be \>1 yr.
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