The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

NCT ID: NCT03531606

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2018-06-30

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.

Conditions

Sigmoid Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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'

Group Type: EXPERIMENTAL

Mechnicov probiotics

Intervention Type: 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'

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'

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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'

Interventions

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'

Intervention Type: 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'

Intervention Type: DRUG

Other Intervention Names

Anterior resection; Anterior resection

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kye Bong-Hyeon

OTHER

Sponsor Role: lead

Responsible Party

Kye Bong-Hyeon

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SungSik Jang, Ph.D

Role: STUDY_DIRECTOR

R &D

Locations

In Kyu Lee

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KY_Mpro3

Identifier Type: -

Identifier Source: org_study_id