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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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'
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'
In Kyu Lee
Seoul, South Korea
Anterior resection syndrome improvement change
3 times performed through questionnaire
Time frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
Bowel examination
2 times performed through questionnaire
Time frame: 4 weeks after surgery, 5 weeks after surgery
Quality of Life of Cancer Patients(EORTC QLQ-C30)
2 times performed through questionnaire
Time frame: 1 week before surgery, 4 weeks after surgery
Markers related Inflammation
WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
Time frame: 1 week before surgery, 4 weeks after surgery
NSI(Nutritional Screening Index)
PG-SGA: Patient-Generated Subjective Global Assessment
Time frame: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Clavien-Dindo Classification
Assessment through "Clavien-Dindo Classification"
Time frame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
NGS, SCFA
NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid)
Time frame: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery
Other biomarkers
Zonulin, other Cytokines
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Time frame: 1 week before surgery, 4 weeks after surgery