Skip to main content
OpenTrials
Completed

NCT Number: NCT03531606

The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sigmoid Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Sigmoid Diseases Sigmoid Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

In Kyu Lee

Seoul, 06591, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Mechnicov probiotics

Drug

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

Drug

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

Primary outcomes

  1. Anterior resection syndrome improvement change

    Time frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery

    3 times performed through questionnaire

Secondary outcomes

  1. Bowel examination

    Time frame: 4 weeks after surgery, 5 weeks after surgery

    2 times performed through questionnaire

  2. Quality of Life of Cancer Patients(EORTC QLQ-C30)

    Time frame: 1 week before surgery, 4 weeks after surgery

    2 times performed through questionnaire

  3. Markers related Inflammation

    Time frame: 1 week before surgery, 4 weeks after surgery

    WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio

  4. 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

  5. Clavien-Dindo Classification

    Time frame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery

    Assessment through "Clavien-Dindo Classification"

  6. 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)

  7. Other biomarkers

    Time frame: 1 week before surgery, 4 weeks after surgery

    Zonulin, other Cytokines

Sponsors and collaborators

Lead sponsor

Kye Bong-Hyeon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 22, 2018
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.