The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

Sigmoid Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531606
• Other study ID #: KY_Mpro3
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Sigmoid Colon Cancer
• Sigmoid Neoplasms

Intervention

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'
• 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'

Locations

Country	Name	City	State
Korea, Republic of	In Kyu Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kye Bong-Hyeon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior resection syndrome improvement change	3 times performed through questionnaire	1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
Secondary	Bowel examination	2 times performed through questionnaire	4 weeks after surgery, 5 weeks after surgery
Secondary	Quality of Life of Cancer Patients(EORTC QLQ-C30)	2 times performed through questionnaire	1 week before surgery, 4 weeks after surgery
Secondary	Markers related Inflammation	WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio	1 week before surgery, 4 weeks after surgery
Secondary	NSI(Nutritional Screening Index)	PG-SGA: Patient-Generated Subjective Global Assessment	1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Secondary	Clavien-Dindo Classification	Assessment through "Clavien-Dindo Classification"	1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
Secondary	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
Secondary	Other biomarkers	Zonulin, other Cytokines	1 week before surgery, 4 weeks after surgery