The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

Not Applicable

Completed

• Conditions: Sigmoid Colon Cancer
• Interventions: Drug: Placebo; Drug: Mechnicov probiotics

• Registration Number: NCT03531606
• Lead Sponsor: Kye Bong-Hyeon

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.

Study Timeline

• Study Start: 2016-12-12
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-22
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator	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 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'
Experimental	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'

Primary Outcome Measures

Name	Time	Method
Anterior resection syndrome improvement change	1 week before surgery, 4 weeks after surgery, 5 weeks after surgery	3 times performed through questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

In Kyu Lee; 🇰🇷 Seoul, Korea, Republic of