Clostridium difficile Colitis

Nontoxigenic C. difficile Helps Prevent Recurrent CDI

Taking nontoxigenic Clostridium difficile (C diff) spores orally decreased the risk for recurrent C. difficile infection (CDI), according to a recent study.

Note: Because nontoxigenic C. difficile (NTCD) strains do not produce toxins, they are able to colonize the gut without invoking disease.
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For the phase 2, randomized, double blind, placebo-controlled, dose-ranging study, researchers monitored 173 adults (18 years and older) with a single CDI episode or 1 recurrence. Each adult had received metronidazole, oral vancomycin, or both at 44 study centers throughout the United States, Canada, and Europe.

Researchers randomly assigned patients to receive 1 of 4 treatments: 104 NTCD spores for 7 days, 107 spores for 7 days, 107 spores for 14 days, or a placebo for 14 days.

Overall, colonization with NTCD-M3 occurred in 69% of patients and CDI recurred less often with NTCD-M3 than with the placebo (11% vs. 30% of patients) by week 6. Fecal colonization also occurred in 71% of patients who received 107 spores, and 63% from the 104 spores group.

Adverse treatment events occurred in 7% of those who received a placeboand 3% of those administered NTCD-M3.

“Among patients with CDI who clinically recovered following treatment with metronidazole or vancomycin, oral administration of spores of NTCD-M3 was well tolerated and appeared to be safe,” wrote the authors of the study.

“Nontoxigenic C difficile strain M3 colonized the gastrointestinal tract and significantly reduced CDI recurrence,” they concluded.

The complete study is published in the May issue of the Journal of the American Medical Association.

-Michelle Canales Butcher

Reference:

Gerding DN, Meyer T, Lee C, et al. Administration of spores of nontoxigenic clostridium difficile strain M3 for prevention of recurrent C difficile infection. JAMA. 2015 April [epub ahead of print] doi: 10.1001/jama.2015.3725.