An open-label study of fecal microbiota transfer in patients with recurrent Clostridium difficile infection has achieved clinical resolution in 96.7% of patients, according to a paper published online Feb. 8 in the Journal of Infectious Diseases.

Researchers treated 30 patients with two different dosing regimens of fractionated and encapsulated stool specimens from healthy donors, given after antibiotic therapy for a current episode of C. difficile infection.

At 8 weeks after dosing, 26 patients (86.7%) had had no C. difficile–positive diarrhea, and of the 4 who did have symptoms, 3 had early self-limiting diarrhea but tested negative for C. difficile carriage at 8 weeks, meaning that overall, 29 of the 30 patients achieved clinical resolution.

Patients also showed significant increases in microbial diversity from day 4 after treatment, and by week 8, the engrafted spore-forming bacteria made up around one-third of the total gut microbial carriage, with no serious adverse events related to the treatment (J Infect Diseases. 2016 Feb. 8. doi: 10.1093/infdis/jiv766 ).

“Although our study is limited by the lack of a placebo arm, the single clinical recurrence of C. difficile diarrhea in this study contrasts starkly with the recurrence rates documented in the placebo arms of three randomized, controlled trials involving patients with similar demographic characteristics and histories of recurrent episodes of [C. difficile infection],” wrote Dr. Sahil Khanna of the Mayo Clinic, Rochester, Minn., and coauthors.

The study was sponsored by Seres Therapeutics. One author reported a consultancy with Seres Therapeutics, and eight authors were employees of and held equity positions in Seres Therapeutics.


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