2013-09-26 20:37:05 UTC

Inside Look at Conducting Fecal Microbiota Transplants

Oct. 1, 2013

NAME

Christina Surawicz, MD

Professor of Medicine, Division of Gastroenterology, Assistant Dean for Faculty Development, University of Washington School of Medicine

 

The idea of using stool from healthy donors to treat patients with gastrointestinal illnesses actually dates back to the fourth century in China, when stool was used to treat food poisoning and diarrheal illnesses.1 Its first use in the U.S. language literature was in 1958 when stool from healthy people was given by enema to several patients with pseudomembranous colitis with improvement in their symptoms.2 1983 saw the first report with what was then called fecal bacteriotherapy to successfully treat recurrent Clostridium difficile (C. difficile) infection (RCDI). When I lectured about C. difficile in those days I said that this was just a measure of the desperation of the patients and their doctors. But by 2004, I had become one of those “desperate” doctors who started to do “stool transplant,” now called fecal microbiota transplant (FMT), to treat a few patients with C. difficile infection which continued to recur despite standard therapy. Some had had recurrent symptoms for over a year. I was impressed with the excellent outcomes and saw that others had similar success rates.

I currently hold an investigational new drug application from the FDA to conduct FMT (though not required, FDA urges physicians to take this step); and I use FMT only for cases of RCDI or rarely for severe refractory C. difficile infection (CDI). I only treat patients who have had multiple recurrences and who have failed a reasonable vancomycin pulse regimen. A good pulse regimen is 125 mg, four times a day, for ten days, followed by one dose (125 mg) every three days, for a total of 10 doses (courtesy of Dr. Scott Curry at the University of Pittsburgh, PA). After three or more recurrences it is unlikely that standard medical therapy will be effective. I make sure that the patient is aware of the risks and benefits of FMT, as well as the risks of colonoscopy or sigmoidoscopy, and make clear that there is no guarantee that this will work and that there could be unknown long-term sequelae. There are few reported complications. My preferred donors are intimate partners or family members. I minimize the risk by screening the donors very carefully for chronic diseases. Some major exclusions are antibiotic use in the prior three months; immune disorders; chronic pain syndromes (for example: fibromyalgia, chronic fatigue); neurologic, neurodevelopmental or neurodegenerative disorders; malignancy; and diarrheal disorders (IBS, IBD, celiac disease). I also screen for transmissible infections both in the blood and in the stool. I test for HIV 1, 2, hepatitis A, B, C and syphilis. Stool is tested for enteric pathogens, rotavirus, giardia, ova and parasite exam, and acid-fast stain. Even with insurance, this may cost the donor several hundred dollars.

I also test the recipient’s blood before FMT for HIV, hepatitis A, B and C, and syphilis. Before the FMT, I ask patients to take a standard colonoscopy prep, even if I am giving stool by sigmoidoscopy. I ask them to continue vancomycin until one to three days prior to the procedure and then to stop it after the procedure. I ask the donor to take a mild laxative the night before and bring in the fresh stool specimen in a disposable container. I mix the stool myself with nonbacteriostatic saline, fill six 50cc syringes and inject it into the colon as proximally as possible thru the suction channel of the colonoscope. I then withdraw the instrument, give the patient two loperamide tablets and ask them to rest supine in our unit for one to two hours. I call the patients by telephone at 24 hours and 14 days and see them in clinic three months later to assess efficacy and look for long-term sequelae. If there is a recurrence, I often repeat the FMT using a different donor.

The 2013 New England Journal of Medicine paper by van Nood, et al. was the first randomized controlled trial to document the efficacy of healthy donor feces in treatment of RCDI. An NIH randomized controlled trial of donor stool by colonoscopy is underway (Principal Investigator: Colleen Kelly). I think that it is unlikely that we will be doing stool transplant in five years. By then, scientists will have identified the key organisms that restore colonization resistance. But, for now, this appears to be the best therapy for patients with RCDI who have not responded to traditional therapy.

Dr. Surawicz had no relevant conflicts to disclose.

References

1. Zhang F, Luo W, Shi Y. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol 2012; 107:1755.

2. Eiseman B, Silen W, Bascom GS et al. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery 1958;44:854-9.

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