Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.023 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.012 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.009 | 0.007 |
| Insufficient payload (model declined to judge) | 0.040 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".