How effective and safe is fecal microbial transplant in preventing C difficile recurrence?
EVIDENCE-BASED ANSWER:
Fecal microbial transplant (FMT) is reasonably safe and effective. In patients who have had multiple Clostridium difficile infections (CDIs), FMT results in a 65% to 80% cure rate with one treatment and 90% to 95% cure rate with repeated treatments compared with a 25% to 27% cure rate for antibiotics (strength of recommendation [SOR]: B, small open-label randomized controlled trials [RCTs]).
Fresh and frozen donor feces, administered by either nasogastric tube or colonoscope, produce equal results (SOR B, RCTs).
FMT has an overall adverse event rate of 30%, primarily involving abdominal discomfort, but also, rarely, severe infections (0.7%) and death (0.1%) (SOR: B, systematic review not limited to RCTs).
A third of patients suffer adverse effects, but serious harms are rare
A systematic review analyzed 50 trials (16 case series, 9 case reports, 4 RCTs, 21 unreported type; 1089 FMT-treated patients) for adverse effects of FMT.5 Most patients (831) had CDIs, 235 had inflammatory bowel disease, and 106 had both conditions. Donor screening tests for FMT included viral screenings (hepatitis A, B, and C; Epstein-Barr virus; human immunodeficiency virus; Treponema pallidum; and cytomegalovirus), stool tests for C difficile toxin, and routine bacterial culture for enteric pathogens (Escherichia coli, Salmonella, Shigella, Yersinia, Campylobacter), ova, and parasites.
Overall, 28.5% of patients receiving FMT experienced adverse events. Upper gastrointestinal (GI) administration resulted in more total adverse events than did lower GI delivery (43.6% vs 20.6%; P value not given), mostly abdominal discomfort. However, upper GI delivery was associated with fewer serious adverse events than was lower GI delivery (2% vs 6%; P value not given). FMT possibly or probably produced serious infections in 0.7% of patients, and there was one colonoscopy-associated death caused by aspiration (0.1% mortality).
RECOMMENDATIONS
Guidelines published by the American College of Gastroenterology in 2013 listed FMT as a treatment option for patients who have had 3 episodes of CDI and vancomycin therapy (based on moderate quality evidence).6
