Oral Microbiome Therapy Made of Purified Firmicutes Spores Effective for Treatment of Recurrent C difficile Infection

Oral Microbiome Therapy Made of Purified Firmicutes Spores Effective for Treatment of Recurrent C difficile Infection

Douglas K. Rex, MD, MASGE, reviewing Feuerstadt P, et al. N Engl J Med 2022 Jan 20.

This study was a double-blind, randomized, placebo-controlled trial. It included patients with ≥3 episodes of C difficile infection (CDI) within 12 months, including the qualifying acute episode. Patients with proven active, recurrent CDI were treated with fidaxomicin or vancomycin with symptom resolution followed by 4 doses of SER-109 (purified Firmicutes spores) or placebo. They were also given 10 ounces of magnesium citrate to drink the night before starting SER-109 or placebo treatment to protect ingested spores from antibiotics. Patients were followed up to 8 weeks after treatment.

The incidence of subsequent recurrence was 12% with SER-109 and 40% with placebo, and the number needed to treat was 3.6. SER-109 was effective in all age groups regardless of antibiotic treatment with vancomycin or fidaxomicin. There were no significant adverse events.

Douglas K. Rex, MD, FASGE

COMMENT

These data indicate that in patients with ≥3 episodes of CDI, oral ingestion of purified Firmicutes spores (following antibiotics with symptom resolution) dramatically reduces the risk of recurrent CDI. This greatly simplifies microbiota transplantation for CDI.

Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.

CITATION(S)

Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an oral microbiome therapy for recurrent Clostridioides difficile infection. N Engl J Med 2022;386:220-229. (https://doi.org/10.1056/nejmoa2106516)

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