The goal of this clinical trial is to evaluate the effects of MPRO3(probiotics mixture) supplementation on surgical outcomes and gut health in patients undergoing surgery for colon cancer.The main question is whether MPRO3 supplementation before and after surgery can reduce postoperative infectious complications compared with placebo.Participants will take either MPRO3 or a placebo once daily for 13 weeks, from 1 week before surgery to 12 weeks after surgery. Researchers will compare the two groups to assess postoperative infectious complications, other clinical outcomes, and changes in the gut microbiome.
A person who is diagnosed histologically or radiologically with adenocarcinoma of the colon and is scheduled to undergo surgery
A person who has received chemotherapy or radiotherapy for colon cancer before surgery
A person with fecal incontinence
A person who has been diagnosed with an acute or serious disease, such as liver, kidney, heart, or thyroid disease, or is taking related medication
A person with alcohol dependence or a history of drug abuse
Parallel
Placebo
Dietary supplementParticipants will receive one placebo capsule orally once daily after breakfast for 13 weeks.
MPRO3
Dietary supplementParticipants will receive one MPRO3 capsule orally once daily after breakfast for 13 weeks.
Postoperative Infectious Complications (Infectious complications)
The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria.
Comprehensive Complication Index
Postoperative complications are graded according to the Clavien-Dindo classification and summarized as a Comprehensive Complication Index score ranging from 0 to 100.
Postoperative Length of Hospital Stay (LOS)
Postoperative length of hospital stay is calculated from the date of surgery to hospital discharge based on medical records.
Inflammation-related Marker 1: Glasgow prognostic score (GPS)
The Glasgow Prognostic Score (GPS) is assessed using inflammatory markers measured in venous blood and is calculated based on serum albumin and high-sensitivity C-reactive protein (HS-CRP) levels. The total score ranges from 0 to 2. A score of 0 is assigned when HS-CRP is ≤10 mg/L and albumin is ≥35 g/L. A score of 1 is assigned when either HS-CRP is \>10 mg/L or albumin is \<35 g/L. A score of 2 is assigned when HS-CRP is \>10 mg/L and albumin is \<35 g/L. Higher scores indicate a worse prognostic status.
Inflammation-related Markers 2: White Blood Cell (WBC), C-reactive protein (CRP), Neutrophils, lymphocytes, Monocytes, Platelets (PLT), neutrophil-to-lymphocyte ratio (NLR)
Inflammation-related markers are assessed using venous blood samples. WBC and Platelets (PLT) are measured in 10\^9/L. Neutrophils, lymphocytes, and Monocytes are reported as percentages (%). CRP is measured in mg/dL. The neutrophil-to-lymphocyte ratio (NLR) is reported as a unitless ratio.
Fecal Microbiome (16S/Shotgun, NGS, SCFA)
Fecal collection kits are sent to participants, who are instructed to collect stool samples at home within 2 days of each visit. The collected samples are placed in the designated kits and returned by courier to the analytical laboratory.
Tumor Transcriptome (RNA-seq)
Normal tissue and tumor tissue are collected during surgery.
Adaptive immunity test (T cell exhaustion marker, CEA/NY-ESO-1/ST4-specific T cell)
Adaptive immunity is assessed using T-cell exhaustion markers and CEA/NY-ESO-1/ST4-specific T-cell responses. These measurements are used to analyze the association between changes in immune status before and after surgery and clinical prognosis, and to evaluate changes in immune response following probiotic intake.
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