NEJM：预防艰难梭菌感染复发，菌群药物SER-109有效！

创作：mildbreeze 审核：mildbreeze 2022年02月01日

①一项3期双盲随机对照试验，182名复发性艰难梭菌感染患者分2组，在常规抗生素治疗后，服用菌群药物SER-109或安慰剂胶囊，持续3天；
②干预后8周内，SER-109组的复发率显著低于安慰剂组（12% vs 40%， RR 0.32），且在不同年龄段和接受不同种类抗生素的患者中均显著降低复发风险；
③SER-109所含菌种可快速、持续地在患者中定植，且次级胆汁酸（抑制艰难梭菌孢子萌发）浓度在SER-109组更高；
④两组的不良事件相似，主要是轻中度胃肠道症状。

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菌群药物复发性艰难梭菌感染 SER-109 随机双盲对照试验 Paul Feuerstadt Barbara H McGovern

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New England Journal of Medicine [IF:158.5]

SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection

SER-109，一种用于复发性艰难梭菌感染的口服微生物组疗法

10.1056/NEJMoa2106516

2022-01-20, Article

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BACKGROUND: Current therapies for recurrent Clostridioides difficile infection do not address the disrupted microbiome, which supports C. difficile spore germination into toxin-producing bacteria. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of recurrent C. difficile infection.
METHODS: We conducted a phase 3, double-blind, randomized, placebo-controlled trial in which patients who had had three or more episodes of C. difficile infection (inclusive of the qualifying acute episode) received SER-109 or placebo (four capsules daily for 3 days) after standard-of-care antibiotic treatment. The primary efficacy objective was to show superiority of SER-109 as compared with placebo in reducing the risk of C. difficile infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed.
RESULTS: Among the 281 patients screened, 182 were enrolled. The percentage of patients with recurrence of C. difficile infection was 12% in the SER-109 group and 40% in the placebo group (relative risk, 0.32; 95% confidence interval [CI], 0.18 to 0.58; P<0.001 for a relative risk of <1.0; P<0.001 for a relative risk of <0.833). SER-109 led to less frequent recurrence than placebo in analyses stratified according to age stratum (relative risk, 0.24 [95% CI, 0.07 to 0.78] for patients <65 years of age and 0.36 [95% CI, 0.18 to 0.72] for those ≥65 years) and antibiotic received (relative risk, 0.41 [95% CI, 0.22 to 0.79] with vancomycin and 0.09 [95% CI, 0.01 to 0.63] with fidaxomicin). Most adverse events were mild to moderate and were gastrointestinal in nature, with similar numbers in the two groups. SER-109 dose species were detected as early as week 1 and were associated with bile-acid profiles that are known to inhibit C. difficile spore germination.
CONCLUSIONS: In patients with symptom resolution of C. difficile infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128. opens in new tab.)