AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients

hy Co., LTD.100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Colon Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A person who is diagnosed histologically or radiologically with adenocarcinoma of the colon and is scheduled to undergo surgery Exclusion Criteria: * 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 * A person with immune system disorders, infectious diseases, or gastrointestinal diseases, including inflammatory bowel disease * A person who is currently diagnosed with or receiving treatment for another type of cancer * A person with renal dysfunction, defined as serum creatinine at least 1.5 times the upper limit of normal, or liver dysfunction, defined as AST and/or ALT at least 2.5 times the upper limit of normal * A person who has continuously used probiotics within the previous week * A person who is pregnant or lactating * A person who has hypersensitivity to the investigational product or any of its ingredients, or an allergy to a specific ingredient * A person who has participated in another human study or drug clinical trial within one month before the start of this study, except for a study involving only non-invasive surveys * A person who is unable to read letters or whose ability is limited * A person deemed inappropriate by the investigator to participate in this study for other reasons

Outcomes

Primary Outcomes

Postoperative Infectious Complications (Infectious complications)

The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria.

Time frame: 4 weeks after surgery, 12 weeks after surgery

Secondary Outcomes

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.

Time frame: 4 weeks after surgery, 12 weeks after surgery

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.

Time frame: 4 weeks after surgery

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.

Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery

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.

Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery

Inflammation Markers 3: Procalcitonin, Blood Culture (BC), Serum Amyloid A (SAA), Zonulin, Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, IL-17)

Procalcitonin, BC, SAA, Zonulin, Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, IL-17) are assessed using venous blood samples. Procalcitonin is measured in ng/mL, SAA in mg/L, and Zonulin in ng/mL. BC is recorded as a qualitative result (Positive/Negative). Cytokines assessed include TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, and IL-17, measured in pg/mL.

Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery

Immune-related Markers 1: Natural Killer cell cytotoxicity (NK cytotoxicity), Natural Killer cell subset (NK subset)

Immune-related markers are assessed using venous blood samples. NK cytotoxicity and NK subset are reported as percentages (%).

Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is used to assess quality of life in patients with cancer. It consists of three domains: global health status/quality of life, functional, and symptom domains, with a total of 30 items. Scores are transformed to a scale ranging from 0 to 100 according to the EORTC QLQ-C30 scoring manual. Higher scores for global health status/quality of life and the functional domain indicate better quality of life, whereas higher scores for the symptom domain indicate worse quality of life.