Fecal Microbiota Transplantation (FMT): A treatment for C. difficile infection
Lawrence J. Brandt, M.D.
Ashish Atreja, M.D.
Learning Objectives:
Participants will be able to:
1) Identify which patients who are appropriate candidates for FMT
2) Develop an FMT protocol: including, donor identification and screening, informed consent, preparation of stool and methods of administration
3) Understand other issues about FMT including: regulatory and reimbursement issues, new sources of donor material, and questions about FMT safety.
Case 2.
A 62-year-old man with a past medical history of GERD, hypertension, and dyslipidemia presents for evaluation of recurrent C. difficile infection (CDI). He initially developed CDI after treatment with ciprofloxacin and metronidazole for diverticulitis 5 months ago. Shortly after completing this course of antibiotics, he developed watery diarrhea and low grade fevers. He was diagnosed with CDI and treated with oral metronidazole for 14 days with incomplete resolution of symptoms. One week later, stools became more profuse and he tested positive for C. difficile toxin by PCR. He then completed a 14-day course of oral vancomycin 125 mg QID. On treatment his bowel movements became formed, but within 5 days of completing the course, he again began to experience profuse, watery stools which tested positive for C. diff. He was referred to a gastroenterologist who recommended a 6-week tapering/pulse-dosed regimen of vancomycin with a probiotic. Once more his stools returned to a semi-formed state on treatment, but 5-7 days after completing the course of vancomycin he again developed watery diarrhea. He was given another tapering regimen of 250 mg QID vancomycin which was extended to 8 weeks. When symptoms recurred 5-7 days later and stool was positive for C. difficile, the gastroenterologist recommended fidaxomicin, but when he went to the pharmacy and was informed his co-pay would be $400 which he could not afford, he was instead placed on vancomycin (liquid, compounded) 125 mg QID and referred for possible FMT.
Questions that might arise during the patient’s interview might be:
1 Do I need an IND or IRB approval to do FMT?
2. How does one choose a donor; who is best?
3. What alternative stool-products are available for patients who have no donor or do not want to use a donor?
4. What tests should be done to qualify a donor?
5. What tests should be done for the recipient?
6. How should the stool be prepared?
7. How much stool/diluent should be used?
8. What route should be used for the FMT and what are the advantages/disadvantages of each route?
9. What are the pre-FMT and post-FMT instructions?
10. What is appropriate informed consent?
11. What adverse effects should the patient be warned about?
12.What follow-up is suggested after FMT ?
13.Should FMT be done again if the patient does not respond or should they be treated with more anti-C. difficile antibiotics??
Case 2.
An 82-year-old woman with multiple myeoma is admitted with sepsis secondary to C. difficile infection. She recently received clindamycin for a dental procedure. The family found her in her home lethargic, and incontinent of liquid stool. On admission the patient had acute renal failure, leukocytosis (25k), and hypotension. She was admitted to the ICU and treated has been treated with vancomycin 500 mg PO QID, vancomycin 500 PR Q8H, and metronidazole 500 IV Q8hr. It is now hospital day 3. She continues to experience watery diarrhea and her abdomen is grossly distended. WBCs went up to over 50K. Lactic acid level is 4. The CT scan shows pancolitis, ascites, and multiple distended loop of small bowel. She was evaluated by the colorectal surgeon who feels she is not a good surgical candidate. The MICU attending has asked you to consult for possible FMT.
Questions that might arise include:
1.What is the evidence supporting FMT in severe-complicated CDI?
2.What are the challenges to performing FMT in this setting?
3.What surgery would you recommend should you decide not to do FMT?