The autohydrolysis of Lentinus edodes was proposed for the extraction of components with antioxidant properties. Operation under non-isothermal conditions was evaluated and compared with isothermal heating. The influence of process severity was assessed in the range of 0.18 to 4.89 (temperature between 50 and 250 °C), up to 80% (d.b.) The influence of process severity during the autohydrolysis of Lentinus edodes was assessed in the range −0.3 to 4.89 (temperature between 50 and 250 °C). Up to 80% (d.b.) of the initial raw material could be solubilized at 210 °C. The different behavior of the saccharide and phenolic fractions was observed with the treatment temperature. Whereas the highest concentration of the saccharide components (mainly glucooligosaccharides) was found at 210 °C, the maximum phenolic yield was identified at 250 °C. The phenolic content and the antiradical properties of the extract showed a continuous increase with the temperature range studied, and at 250 °C, showed antiradical properties comparable to synthetic antioxidants. Autohydrolysis liquid fractions were used as solvents in the formulation of bioactive starch-based hydrogels, identifying a positive correlation between the gel softening and the extracts’ bioactivity features.

BACKGROUND Most of colorectal cancer diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. It seems that the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. OBJECTIVE Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of the nutraceutical fungal extract MICODIGEST 2.0 on the complications of surgery for colorectal cancer resection. METHODS Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation in the multidisciplinary tumor board, patients who fulfill criteria will be screened, stratified according to the tumor location and randomly allocated to be treated with MICODIGEST 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will also undergo a medical and clinical evaluation, which will include baseline and before admission quality of life, microbiome composition, inflammatory and nutritional status, adverse events and adherence. The main endpoint of the study is the surgery complication rate. We will evaluate them using the Clavien-Dindo classification. It would be necessary to recruit a total of 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status and quality of life, as well as the effect of these variables on the surgical complications. RESULTS This study was funded in 2020 by the Center for Industrial Technology Development. The recruitment started in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. CONCLUSIONS The results of this protocol study could help to reduce the surgery complications in patients with colorectal cancer using the new treatment MICODIGEST. Apart from this treatment, this study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. CLINICALTRIAL Clinical Trials.gov. Identifier: NCT04821258. Registered on March 29, 2021.

Background Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID) DERR1-10.2196/34292