NEJM: SER-109 Oral Microbiome Therapy for Recurrent Clostridium difficile Infections

Current therapies for recurrent C.
difficile infections do not address the disrupted microbiome, which promotes the germination of C.
difficile spores into toxin-producing bacteria
.

In a recent study published in the top medical journal NEJM, researchers conducted a Phase 3, double-blind, randomized, placebo-controlled trial in patients with 3 or more episodes of C.
difficile infection (including eligible Acute exacerbation) patients received SER-109 or placebo (four capsules per day for 3 days) after standard antibiotic
therapy .

The primary efficacy objective of the study was the advantage of SER-109 compared to placebo in reducing the risk of recurrence of C.
difficile infection up to 8 weeks after treatment
.

Of the 281 patients screened, a total of 182 patients were included in the study
.

The relative risk was 0.
24 [95% CI, 0.
07 to 0.
78] for patients aged <65 years, 0.
36 [95% CI, 0.
18 to 0.
72] for patients aged ≥65 years according to age group and antibiotics (vancomycin SER-109 resulted in a lower frequency of relapse than placebo in an analysis stratified by the relative risk of serotonin, 0.
41 [95% CI, 0.
22 to 0.
79], and 0.
09 [95% CI, 0.
01 to 0.
63] of fidaxomicin
.

CONCLUSIONS: In patients whose symptoms of C.
difficile infection resolved after treatment with standard antibiotics, oral SER-109 was superior to placebo in reducing the risk of recurrent infection
.