Fecal Transplants Bring Hope to Patients, Challenge the FDA

Janis C. Kelly


December 15, 2014

In This Article

Seeking Alternatives to Antibiotic Treatment for CDI

FMT's Quick Emergence

The high failure rate of antibiotic therapy led to contemporary interest in FMT. Although some form of fecal transfer was used in the fourth and 16th centuries by early medical practitioners Ge Hong and Li Shizhen, respectively,[9] interest notably increased after publication of a proof-of-concept paper by Silverman and colleagues in 2010.[10] They described successful self-administered FMT (performed at home) using low-volume enemas by seven patients who had chronic relapsing CDI that was refractory to other treatment. None of the patients had recurrent CDI after the FMT (including the three patients who later required antibiotics for urinary tract infection or perioperative prophylaxis for hip replacement), and there were no adverse effects.

Recipients and donors were instructed to use one bottle of normal (nonbacteriostatic) saline, a standard 2-quart enema bag kit, and a standard 1-L blender. Stool from the donor (50 mL) was obtained less than 30 minutes before administration, added to 200 mL of normal saline in the blender, and mixed to a "milkshake" consistency. The mixture (about 250 mL) was poured into the enema bag and administered to the patient, who was instructed to lie on the left side and hold the infusate as long as possible.

The authors commented that the success of low-volume enema FMT showed that repopulation of the colon with normal flora could be done without colonoscopy or nasogastric intubation.[10]

Brandt and colleagues[11] later reported a multicenter long-term follow-up study in 77 of 94 patients who had colonoscopic FMT for recurrent CDI. Diarrhea resolved in 74% and 84% of patients within 3 and 5 days after FMT, respectively. There was a primary cure rate of 91%, and no definite FMT-related adverse effects.

van Nood and colleagues[12] also reported that FMT was three times more effective than vancomycin in treating recurrent C difficile infection in a randomized study of 43 patients. This interim analysis brought the trial to an early halt. The only significant differences in adverse events were mild diarrhea and abdominal cramping in the infusion group on the day of infusion. The authors reported that after FMT, fecal bacterial diversity in the patients became similar to that in healthy donors.

Mainstream Acceptance

In the wake of such encouraging studies, patients with recurrent C difficile began to approach gastroenterologists and infectious disease specialists, seeking FMT; the specialists in turn began to offer the procedure. Catherine Duff, a patient with C difficile, set up The Fecal Transplant Foundation after undergoing a self-administered FMT at home with her husband's stool and the help of a physician who had it tested for safety. Patients also set up The Power of Poop, an informational website.

By the end of 2012, dozens of clinicians in several countries were administering FMT, with researchers experimenting with both frozen stool in capsules and biosynthetic preparations based on organisms found in normal, healthy stool. Private companies began offering testing of donor stool samples (about $800 per sample, usually not reimbursable by insurance).


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