How effective and safe is fecal microbial transplant in preventing &lt;i&gt;C difficile&lt;/i&gt; recurrence?

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Clinical Inquiries

How effective and safe is fecal microbial transplant in preventing C difficile recurrence?

J Fam Pract. 2018 June;67(6):386-388

By

Shawn Meyers, MD

Jessica Shih, PharmD

Jon O. Neher, MD

Sarah Safranek, MLIS

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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).

References

1. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013;368:407-415.

2. Cammarota G, Masucci L, Ianiro G, et al. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015;41:835-843.

3. Lee CH, Steiner T, Petrof EO, et al. Frozen vs fresh fecal microbiota transplantation and clinical resolution of diarrhea in patients with recurrent Clostridium difficile infection. JAMA. 2016;315:142-149.

4. Youngster I, Sauk J, Pindar C, et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014;58:1515-1522.

5. Wang S, Xu M, Wang W, et al. Systematic review: adverse events of fecal microbiota transplantation. PLoS One. 2016;11:e0161174.

6. Surawicz CM, Brandt LJ, Binion DG, et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013;108:478-498.

EVIDENCE SUMMARY

An open-label RCT enrolled 41 immunocompetent older adults who had relapsed CDI after at least one course of antibiotic therapy.¹ Investigators randomized patients to 3 treatment groups:

vancomycin therapy, bowel lavage (with 4 L nasogastric polyethylene glycol solution), and nasogastric-infused fresh donor feces;
vancomycin with nasogastric bowel lavage without donor feces; or
vancomycin alone.

Researchers defined cure as the absence of diarrhea or 3 negative stool samples (if patients continued to have persistent diarrhea) at 10 weeks without relapse.

Thirteen of 16 patients (81%) in the donor feces infusion group were cured with the first infusion. Two of the 3 remaining patients were cured after a second donor transplant. FMT produced higher total cure rates than those of vancomycin (94% vs 27%; P<.001; number needed to treat [NNT]=2). Bowel lavage had no effect on outcome.

FMT cures more patients than vancomycin alone

An open-label RCT of 39 patients compared healthy-donor, fresh FMT given via colonoscopy with vancomycin alone for recurrent CDIs.² Researchers recruited immunocompetent adults who had recurrent CDIs after at least one course of vancomycin or metronidazole.

Patients in the treatment group received a short course of vancomycin, followed by bowel cleansing and fecal transplant via colonoscopy. Clinicians repeated the fecal transplant every 3 days until resolution for patients with pseudomembranous colitis. Patients in the control group were treated with vancomycin for at least 3 weeks. Researchers defined cure as the absence of diarrhea or 2 negative stool samples (if patients continued to have diarrhea) at 10 weeks without relapse.

Thirteen of 20 patients in the FMT group (65%) achieved cure after the first fecal infusion. The 7 remaining patients received multiple infusions; 5 were cured. Overall, FMT cured more patients than vancomycin alone (90% vs 26%; odds ratio=25.2; 99.9% confidence interval [CI], 1.26-502; NNT=2).

Continue to: Fresh and frozen stool are equally effective

Evidence-based answers from the Family Physicians Inquiries Network

How effective and safe is fecal microbial transplant in preventing C difficile recurrence?

EVIDENCE-BASED ANSWER:

References

EVIDENCE SUMMARY

FMT cures more patients than vancomycin alone

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