Table 3 The latest FDA approved live microbiome therapeutic products
From: Critical role of the gut microbiota in immune responses and cancer immunotherapy
Microbiome therapeutic product name | Participants | Trial design | Group | Results | |||
|---|---|---|---|---|---|---|---|
Treatment success rates (after 8Â weeks) (%) | Sustained clinical response (between 8Â weeks to 6Â months) | Adverse events | The number of engrafting dose species (after 8Â weeks) | ||||
RBX2660 | 267 participants with rCDI were included, 180 in RBX2660 group and 87 in Placebo group | 1. A randomized, double-blind trial | RBX2660 | 70.6 | 92.1% | 55.6% (after 6 months) | – |
2. Intention-to-treat population used in statistical analysis | Placebo | 57.5 | 90.6% | 44.8% (after 6 months) | – | ||
SER-109 | 182 participants with rCDI were included, 89 in SER-109 group and 93 in Placebo group | 1. A randomized, double-blind trial | SER-109 | 87.6 | – | 51.1% (after 8 weeks) | 66 |
2. Intention-to-treat population used in statistical analysis | Placebo | 60.2 | – | 52.2% (after 8 weeks) | 56 | ||