Back to resultsThe Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
Primary Purpose
Sigmoid Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mechnicov probiotics
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sigmoid Colon Cancer
Eligibility Criteria
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
Sites / Locations
- In Kyu Lee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo comparator
Arm Description
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 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'
Outcomes
Primary Outcome Measures
Anterior resection syndrome improvement change
3 times performed through questionnaire
Secondary Outcome Measures
Bowel examination
2 times performed through questionnaire
Quality of Life of Cancer Patients(EORTC QLQ-C30)
2 times performed through questionnaire
Markers related Inflammation
WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
NSI(Nutritional Screening Index)
PG-SGA: Patient-Generated Subjective Global Assessment
Clavien-Dindo Classification
Assessment through "Clavien-Dindo Classification"
NGS, SCFA
NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid)
Other biomarkers
Zonulin, other Cytokines
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03531606
Brief Title
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
Official Title
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kye Bong-Hyeon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sigmoid Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study has been designed for randomized, double Blinded, placebo clinical trial.
Masking
Care Provider
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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'
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
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'
Intervention Type
Drug
Intervention Name(s)
Mechnicov probiotics
Other Intervention Name(s)
Anterior resection
Intervention Description
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'
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Anterior resection
Intervention Description
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'
Primary Outcome Measure Information:
Title
Anterior resection syndrome improvement change
Description
3 times performed through questionnaire
Time Frame
1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
Secondary Outcome Measure Information:
Title
Bowel examination
Description
2 times performed through questionnaire
Time Frame
4 weeks after surgery, 5 weeks after surgery
Title
Quality of Life of Cancer Patients(EORTC QLQ-C30)
Description
2 times performed through questionnaire
Time Frame
1 week before surgery, 4 weeks after surgery
Title
Markers related Inflammation
Description
WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
Time Frame
1 week before surgery, 4 weeks after surgery
Title
NSI(Nutritional Screening Index)
Description
PG-SGA: Patient-Generated Subjective Global Assessment
Time Frame
1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Title
Clavien-Dindo Classification
Description
Assessment through "Clavien-Dindo Classification"
Time Frame
1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
Title
NGS, SCFA
Description
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
Title
Other biomarkers
Description
Zonulin, other Cytokines
Time Frame
1 week before surgery, 4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SungSik Jang, Ph.D
Organizational Affiliation
R &D
Official's Role
Study Director
Facility Information:
Facility Name
In Kyu Lee
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
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