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Intestinal microbiota capsules are an investigational live biotherapeutic product (LBP) consisting of a concentrated consortium of commensal bacteria derived from healthy human donors. Developed and studied by the First Affiliated Hospital of Ningbo University, these capsules are used for fecal microbiota transplantation (FMT) in the neoadjuvant setting for locally advanced rectal cancer (LARC). The therapy is administered orally in conjunction with the PD-1 inhibitor sintilimab and standard long-course chemoradiotherapy. The primary objective of this microbial therapy is to modulate the patient's gut microbiome to enhance the efficacy of immune checkpoint inhibition and potentially reduce the gastrointestinal toxicity associated with pelvic radiation and chemotherapy. Each dose typically contains approximately 1 x 10^13 bacteria.
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