Bifid triple viable bacteria combined with montmorillonite powder is associated with lower intestinal barrier biomarker levels and faster postoperative recovery after laparoscopic colorectal cancer surgery: a randomized controlled trial

Objective To evaluate whether bifid triple viable bacteria combined with montmorillonite powder is associated with intestinal mucosal barrier biomarkers and postoperative outcomes after laparoscopic colorectal cancer (CRC) surgery. Methods This prospective, single-center randomized controlled trial enrolled 114 confirmed CRC patients and randomized them 1:1 to treatment or control groups. The treatment group received bifid triple viable bacteria plus montmorillonite powder on postoperative days 1–4 in addition to standard care, whereas controls received standard care alone. Per-protocol and modified intention-to-treat analyses included 86 and 107 patients, respectively. The primary outcome was serum D-lactate on postoperative day 5; secondary outcomes included endotoxin, diamine oxidase, inflammatory biomarkers, gastrointestinal recovery, hospital stay, complications, and safety. Results In the per-protocol analysis, on postoperative day 5, the treatment group had lower D-lactate [0.229 ± 0.076 vs. 0.410 ± 0.139 μg/mL], endotoxin [0.079 ± 0.023 vs. 0.153 ± 0.057 EU/mL], and diamine oxidase [5.54 ± 1.93 vs. 10.00 ± 4.02 U/L] than controls (all P < 0.001). The D-lactate mean difference was −0.181 μg/mL (95% CI, −0.229 to −0.132; t = −7.458). IL−1, TNF-α, and CRP were also lower (all P < 0.001); the WBC difference had an unadjusted P = 0.007 and a Bonferroni-adjusted P = 0.057. Times to first bowel sounds, flatus, defecation, and semi-liquid diet tolerance were significantly shorter (all P < 0.001), and postoperative hospital stay was reduced [9.0 (7.0–10.0) vs. 12.0 (9.0–14.0) days, P < 0.001]. Overall complications were lower in both per-protocol (11.6% vs. 37.2%; unadjusted P = 0.012, Bonferroni-adjusted P = 0.084) and modified intention-to-treat analyses (9.4% vs. 38.9%, P < 0.001). Conclusion This combined regimen was associated with lower intestinal barrier and inflammatory biomarker levels, faster gastrointestinal recovery, and shorter hospitalization after laparoscopic CRC surgery. The lower overall complication rate was an exploratory finding. Clinical Trial Registration : identifier ChiCTR2300078918.