The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

Kye Bong-Hyeon

Status: Completed

Conditions: Sigmoid Colon Cancer

Treatments: Drug: Mechnicov probiotics; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03531606

KY_Mpro3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

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'

Treatment:

Drug: Mechnicov probiotics

Placebo comparator

Placebo Comparator group

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'

Treatment:

Drug: Placebo