The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

Study Overview
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Brief Summary
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The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.

Detailed Description
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The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.

Official Title
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The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial

Conditions
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Sigmoid Colon Cancer

Intervention / Treatment
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* Drug: Mechnicov probiotics
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female aged 20 to over 75 years old As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial. Exclusion Criteria: Those who have metastatic colorectal cancer screening Those who have urinary incontinence or fecal incontinence Those who received preoperative chemotherapy or radiotherapy Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy) Those who have neurologist or psychologically important psychiatric history or current disease Those who have alcohol addiction, substance abuse Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease) Those who have uncontrolled hypertension, diabetes patients Those who have creatinine with more than twice from normal upper limit in site Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site Those who have probiotics, antibiotics, continually within the last one week Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial under the investigator's judgment, those who is not qualified to participate this clinical trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study has been designed for randomized, double Blinded, placebo clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' | Drug: Mechnicov probiotics<br>* Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'<br>* Other names: Anterior resection;|
| Placebo Comparator: Placebo comparator<br>Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' | Drug: Placebo<br>* Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'<br>* Other names: Anterior resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior resection syndrome improvement change | 3 times performed through questionnaire | 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel examination | 2 times performed through questionnaire | 4 weeks after surgery, 5 weeks after surgery | 
| Quality of Life of Cancer Patients(EORTC QLQ-C30) | 2 times performed through questionnaire | 1 week before surgery, 4 weeks after surgery | 
| Markers related Inflammation | WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio | 1 week before surgery, 4 weeks after surgery | 
| NSI(Nutritional Screening Index) | PG-SGA: Patient-Generated Subjective Global Assessment | 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery | 
| Clavien-Dindo Classification | Assessment through Clavien-Dindo Classification | 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery | 
| NGS, SCFA | NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid) | 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery | 
| Other biomarkers | Zonulin, other Cytokines | 1 week before surgery, 4 weeks after surgery |