Clinical trial NCT03531606: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sigmoid Colon Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has been designed for randomized, double Blinded, placebo clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anterior resection syndrome improvement change
timeFrame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
Secondary outcomes:
measure: Bowel examination
timeFrame: 4 weeks after surgery, 5 weeks after surgery
measure: Quality of Life of Cancer Patients(EORTC QLQ-C30)
timeFrame: 1 week before surgery, 4 weeks after surgery
measure: Markers related Inflammation
timeFrame: 1 week before surgery, 4 weeks after surgery
measure: NSI(Nutritional Screening Index)
timeFrame: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
measure: Clavien-Dindo Classification
timeFrame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
measure: NGS, SCFA
timeFrame: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery
measure: Other biomarkers
timeFrame: 1 week before surgery, 4 weeks after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: In Kyu Lee
Study officials:
affiliation: R &D
name: SungSik Jang, Ph.D
role: STUDY_DIRECTOR
References: