Probiotic May Reduce Colorectal Adenoma Recurrence in High-Risk Groups

Treatment with Clostridium butyricum MIYAIRI 588 (CBM588) may potentially reduce colorectal adenoma recurrence among patients with a history of colorectal adenomas completely resected by endoscopic resection, according to findings from a single-blind, crossover trial (NCT06855355) published in Oncology Research.¹

Among patients treated in intent-to-treat (ITT) population in group A (n = 200), which received CBM588 in the first year of the study, a lower mean polyp number was observed vs in group B (n = 198), which did not receive treatment in the first year; the respective values were 0.78 (SD, 0.09) and 1.00 (SD, 0.10). This did not reach statistical significance (P = .10). However, the per protocol (PP) analysis did show a significant difference in mean polyp numbers between cohorts A (n = 168) and B (n = 85), at 0.80 (SD, 0.10) vs 1.25 (SD, 0.16; P <.05).

Additionally, in the ITT analysis, 56.50% vs 47.98% of groups A and B, respectively, did not have polyps after 1 year; 55.95% vs 41.18% were polyp-free after 1 year in the PP analysis. Furthermore, in the ITT and PP analysis, the number of patients with no more than 1 polyp was 77.00% vs 69.19% (P = .08) and 55.95% vs 41.18% (P <.05), respectively.

In the ITT analysis, 30.00% of group A vs 35.35% of group B developed adenomas (P = .26), with 29.76% and 44.71% developing adenomas in the PP analysis (P <.05). Additionally, median polyp size did not significantly differ between groups in the ITT and PP analysis.

“This randomized crossover trial demonstrates that CBM588 has the potential to significantly reduce colorectal adenoma recurrence, particularly in individuals with high treatment adherence. While the reduction in mean polyp number did not reach statistical significance in the ITT analysis, the consistent and substantial decreases observed in the PP analysis underscore the clinical relevance of CBM588’s effects,” Jiunn-Wei Wang, MD, Clinical Assistant Professor of the Department of Medicine at Kaohsiung Medical University in Taiwan, wrote in the publication with study coinvestigators.¹

Patients in the crossover trial were initially assigned 1:1 to receive 1g of oral CBM588 twice daily for a year, followed by a 3-month washout period and no treatment for the second year (n = 200), or no treatment for the first year, followed by a 3-month washout period and twice-daily oral CBM588 (n = 200). A 3-month washout was initiated to allow for the normalization of the gut microbiome and immune responses, and a placebo was not implemented due to ethical and logistical considerations.

Those eligible for enrollment on the trial included adult patients with previously resected colorectal adenomas within the past 3 years and a subsequent presentation of recurrent colorectal polyps detected during surveillance colonoscopy. Patients excluded from study entry included those with a prior gastrointestinal malignancy, inflammatory bowel disease, or familial adenomatous polyposis, as well as those who received antibiotics or probiotics within 3 months of study start.

In the ITT populations of group A and B, the mean age was 62.34 (SD, 0.66) and 59.75 (SD, 0.61) and 52.50% vs 52.02% were male. A total of 25.00% vs 20.71% and 19.00% vs 16.67% had a smoking and alcohol consumption history, respectively. Additionally, the body mass index between both groups was 24.18 (SD, 0.24) and 24.00 (SD, 0.25).

The primary end point of the trial was colorectal polyp recurrence rate.² Secondary end points included adenomatous polyp recurrence rates, the mean number of recurrent polyps, and the polyp location distribution.

“These results highlight CBM588 as a promising, non-invasive strategy for adenoma prevention, especially in high-risk populations. Given its favorable safety profile and biological plausibility, further large-scale, placebo-controlled trials are warranted to confirm its preventive efficacy and to elucidate the underlying mechanisms,” Wang concluded with the study authors.

Reference

1. Wang JW, Hsu WH, Yu FJ, et al. Clostridium butyricum MIYAIRI 588 reduces colorectal adenomatous polyp recurrence: a randomized crossover trial. Oncol Res. 2025;33(12):3907-3922. doi:10.32604/or.2025.070432
2. CBM588 reduces colorectal polyp recurrence. ClinicalTrials.gov. Updated May 16, 2025. Accessed January 6, 2026. https://tinyurl.com/3m5xrkpa