The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

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

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.

Study Overview

• Status: Completed
• Conditions: Sigmoid Colon Cancer
• Intervention / Treatment: Drug: Mechnicov probiotics; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • In Kyu Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult male or female aged 20 to over 75 years old
2. As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
3. Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.

Exclusion Criteria:

1. Those who have metastatic colorectal cancer screening
2. Those who have urinary incontinence or fecal incontinence
3. Those who received preoperative chemotherapy or radiotherapy
4. 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)
5. Those who have neurologist or psychologically important psychiatric history or current disease
6. Those who have alcohol addiction, substance abuse
7. Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
8. Those who have uncontrolled hypertension, diabetes patients
9. Those who have creatinine with more than twice from normal upper limit in site
10. Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
11. Those who have probiotics, antibiotics, continually within the last one week
12. Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
13. Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
14. under the investigator's judgment, those who is not qualified to participate this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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'	Drug: Mechnicov probiotics; 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'; Other Names: Anterior resection
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'	Drug: Placebo; 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'; Other Names: Anterior resection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kye Bong-Hyeon
• Investigators: Study Director: SungSik Jang, Ph.D, R &D

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 15, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Sigmoid Diseases; Colonic Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: KY_Mpro3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No