Perioperative administration of CBM588 in colorectal cancer radical surgery: A single-center, randomized controlled trial.

Clostridium butyricum MIYAIRI 588 (CBM588) has been used to treat gastrointestinal disorders and recently found to enhance efficacy of checkpoint inhibitor in solid tumors. However, limited studies spotlight the role of CBM588 in perioperative management of colorectal cancer (CRC) radical surgery. Here, we report a phase 4, open-label, randomized controlled trial (ChiCTR2000033883) to assess the safety and short-term efficacy of CBM588 as a perioperative, adjunctive therapy. The primary efficacy indicator is postoperative intestinal function assessed by time to first flatus, recovery time of defecation, and first intake of delicate fluid and semi-fluid. Secondary outcomes are incidence of postoperative complications and immune status. We find that perioperative administration of CBM588 significantly benefits recovery of intestinal function, lowers risk of infectious complications, and enhances systemic immunity by increasing circulating T cells. CBM588 serves as a promising probiotic with favorable tolerability in CRC patients undergoing radical surgery.