Colon Neoplasms
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Participants will receive one placebo capsule orally once daily after breakfast for 13 weeks.
DIETARY_SUPPLEMENTMPRO3
Participants will receive one MPRO3 capsule orally once daily after breakfast for 13 weeks.
Sponsors
hy Co., LTD.
Nutriworks
ImmunoBiome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Infectious Complications (Infectious complications) | 4 weeks after surgery, 12 weeks after surgery | The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index | 4 weeks after surgery, 12 weeks after surgery | 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) | 4 weeks after surgery | 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) | Baseline, 4 weeks after surgery, 12 weeks after surgery | 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) | Baseline, 4 weeks after surgery, 12 weeks after surgery | 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. |
| 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) | Baseline, 4 weeks after surgery, 12 weeks after surgery | 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. |
| Immune-related Markers 1: Natural Killer cell cytotoxicity (NK cytotoxicity), Natural Killer cell subset (NK subset) | Baseline, 4 weeks after surgery, 12 weeks after surgery | Immune-related markers are assessed using venous blood samples. NK cytotoxicity and NK subset are reported as percentages (%). |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) | 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery | 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. |
| Bowel Function Assessment 1: Bowel Diary | 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery | As part of the bowel function assessment, a bowel diary is used to record the frequency and form of bowel movements. |
| Bowel Function Assessment 2: Postoperative Bowel Function Questionnaire | 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery | As part of the bowel function assessment, the Postoperative Bowel Function Questionnaire is used to assess postoperative bowel function and recovery, including time to first passage of flatus, time to first bowel movement, and other related measures. |
| Nutritional Status Assessment 1: Patient-Generated Subjective Global Assessment (PG-SGA) | 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery | As part of the nutritional status assessment, the Patient-Generated Subjective Global Assessment (PG-SGA) is used to evaluate nutritional status based on factors including changes in body weight and dietary intake, gastrointestinal symptoms affecting food intake, physical examination findings, and comorbidities. |
| Nutritional Status Assessment 2: Prognostic Nutritional Index (PNI) | 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery | As part of the nutritional status assessment, the Prognostic Nutritional Index (PNI) is calculated based on Serum Albumin and Total Lymphocyte Count. PNI is calculated as 10 × Serum Albumin (g/dL) + 0.005 × Total Lymphocyte Count (/mm³). |
Countries
South Korea
Contacts
CONTACTNayeon Song
Outcome results
None listed