The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

July 16, 2018 updated by: Kye Bong-Hyeon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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'

Other Names:
  • Anterior resection
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

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'

Other Names:
  • Anterior resection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anterior resection syndrome improvement change
Time Frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
3 times performed through questionnaire
1 week before surgery, 4 weeks after surgery, 5 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bowel examination
Time Frame: 4 weeks after surgery, 5 weeks after surgery
2 times performed through questionnaire
4 weeks after surgery, 5 weeks after surgery
Quality of Life of Cancer Patients(EORTC QLQ-C30)
Time Frame: 1 week before surgery, 4 weeks after surgery
2 times performed through questionnaire
1 week before surgery, 4 weeks after surgery
Markers related Inflammation
Time Frame: 1 week before surgery, 4 weeks after surgery
WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
1 week before surgery, 4 weeks after surgery
NSI(Nutritional Screening Index)
Time Frame: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
PG-SGA: Patient-Generated Subjective Global Assessment
1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Clavien-Dindo Classification
Time Frame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
Assessment through "Clavien-Dindo Classification"
1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
NGS, SCFA
Time Frame: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery
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
Other biomarkers
Time Frame: 1 week before surgery, 4 weeks after surgery
Zonulin, other Cytokines
1 week before surgery, 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kye Bong-Hyeon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SungSik Jang, Ph.D, R &D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY_Mpro3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings