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
Cristina Regueiro,
Astrid Irene Diez Martín,
Sonia Pérez,
Carlos Daviña-Núñez,
Sara Zarraquiños,
David Remedios,
Cristina Alejandra Sánchez Gómez,
Sara Alonso Lorenzo,
Romina Fernández Poceiro,
María Luisa de Castro Parga,
Vicent Hernández Ramírez,
Arturo Rodríguez-Blanco,
Esteban Sinde,
Catalina Fernández-de-Ana,
Joaquín Cubiella
Affiliations
Cristina Regueiro
Research Group in Gastrointestinal Oncology Disease in Ourense, 32005 Ourense, Spain
Astrid Irene Diez Martín
Research Group in Gastrointestinal Oncology Disease in Ourense, 32005 Ourense, Spain
Sonia Pérez
Microbiology and Infectology Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), 36312 Vigo, Spain
Carlos Daviña-Núñez
Microbiology and Infectology Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), 36312 Vigo, Spain
Sara Zarraquiños
Department of Gastroenterology, Hospital Universitario de Ourense, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), 32005 Ourense, Spain
David Remedios
Department of Gastroenterology, Hospital Universitario de Ourense, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), 32005 Ourense, Spain
Cristina Alejandra Sánchez Gómez
Department of Gastroenterology, Hospital Universitario de Ourense, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), 32005 Ourense, Spain
Sara Alonso Lorenzo
Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36312 Vigo, Spain
Romina Fernández Poceiro
Research Group in Gastroenterology, Galicia Sur Health Research Institute, 36312 Vigo, Spain
María Luisa de Castro Parga
Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36312 Vigo, Spain
Vicent Hernández Ramírez
Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36312 Vigo, Spain
Arturo Rodríguez-Blanco
Hifas da Terra S.L., 36154 Pontevedra, Spain
Esteban Sinde
Hifas da Terra S.L., 36154 Pontevedra, Spain
Catalina Fernández-de-Ana
Hifas da Terra S.L., 36154 Pontevedra, Spain
Joaquín Cubiella
Research Group in Gastrointestinal Oncology Disease in Ourense, 32005 Ourense, Spain
Background/Objectives: 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. Methods: 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. Results: 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%; p = 0.9). In non-robotic surgery, we identified a non-significant reduction in postoperative complications (Micodigest 2.0: 25.0%, placebo: 36.4%; p = 0.7), as well as a significant increase in lymphocyte levels and a reduction in the neutrophil-to-lymphocyte ratio (p = 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 (p = 0.004) and Actinobacteria (p = 0.04). Conclusions: Micodigest 2.0 supplementation was associated with non-significant reductions in postoperative complications and significant modifications in gut microbiota composition. Limitations: The trial did not reach the calculated sample size.
