The Effect of Fungal Nutraceutical Supplementation on Postoperative Complications, Inflammatory Factors and Fecal Microbiota in Patients Undergoing Colorectal Cancer Surgery with Curative Intent: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial.

The combination of different fungal extracts could be beneficial to cancer patients due to their role in gut microbiota modulation and anti-inflammatory activity. The study aimed to evaluate whether fungal extract supplementation reduces postsurgical complications in patients with colorectal cancer undergoing curative surgery. Patients were randomized to receive the nutraceutical Micodigest 2.0 or a placebo until surgery. Surgical complications were evaluated using the Clavien-Dindo classification. We also assessed the effect of the nutraceutical on gut microbiota composition, inflammatory response, nutritional status, and quality of life. A subanalysis based on surgery type (robotic vs. non-robotic) was performed. We included 46 patients who met the inclusion criteria, with 27 randomized to the intervention group and 19 to the placebo group, receiving treatment for three (2-4) weeks. Non-robotic surgery was performed in 35 (76.1%) patients. We found non-significant differences in postoperative complications (Micodigest 2.0: 25.9%, placebo: 26.3%; = 0.9). In non-robotic surgery, we identified a non-significant reduction in postoperative complications (Micodigest 2.0: 25.0%, placebo: 36.4%; = 0.7), as well as a significant increase in lymphocyte levels and a reduction in the neutrophil-to-lymphocyte ratio ( = 0.02). Micodigest 2.0 supplementation was also associated with significant changes in gut microbiota composition, as indicated by a decreased relative abundance of the phyla Firmicutes ( = 0.004) and Actinobacteria ( = 0.04). Micodigest 2.0 supplementation was associated with non-significant reductions in postoperative complications and significant modifications in gut microbiota composition. The trial did not reach the calculated sample size.