NCT03531606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

April 15, 2018

Last Update Submit

July 16, 2018

Conditions

Sigmoid Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Anterior resection syndrome improvement change

    3 times performed through questionnaire

    1 week before surgery, 4 weeks after surgery, 5 weeks after surgery

Secondary Outcomes (7)

  • Bowel examination

    4 weeks after surgery, 5 weeks after surgery

  • Quality of Life of Cancer Patients(EORTC QLQ-C30)

    1 week before surgery, 4 weeks after surgery

  • Markers related Inflammation

    1 week before surgery, 4 weeks after surgery

  • NSI(Nutritional Screening Index)

    1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery

  • Clavien-Dindo Classification

    1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery

  • +2 more secondary outcomes

Study Arms (2)

Experimental

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'

Drug: Mechnicov probiotics

Placebo comparator

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'

Drug: Placebo

Interventions

Mechnicov probioticsDRUG

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'

Also known as: Anterior resection
Experimental
PlaceboDRUG

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'

Also known as: Anterior resection
Placebo comparator

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female aged 20 to over 75 years old
  • As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
  • Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.

You may not qualify if:

  • Those who have metastatic colorectal cancer screening
  • Those who have urinary incontinence or fecal incontinence
  • Those who received preoperative chemotherapy or radiotherapy
  • 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)
  • Those who have neurologist or psychologically important psychiatric history or current disease
  • Those who have alcohol addiction, substance abuse
  • Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
  • Those who have uncontrolled hypertension, diabetes patients
  • Those who have creatinine with more than twice from normal upper limit in site
  • Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
  • Those who have probiotics, antibiotics, continually within the last one week
  • Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
  • Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
  • under the investigator's judgment, those who is not qualified to participate this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

In Kyu Lee

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Colonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid Diseases

Study Officials

  • SungSik Jang, Ph.D

    R &D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study has been designed for randomized, double Blinded, placebo clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 22, 2018

Study Start

December 12, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)