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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 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' |
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| Placebo comparator | Placebo Comparator | 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' |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechnicov probiotics | Drug | 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' |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SungSik Jang, Ph.D | R &D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| In Kyu Lee | Seoul | 06591 | South Korea |
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| ID | Term |
|---|---|
| D012811 | Sigmoid Neoplasms |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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This study has been designed for randomized, double Blinded, placebo clinical trial.
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| Placebo | Drug | 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' |
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| 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 |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012810 | Sigmoid Diseases |