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Trial record 10 of 978 for:    colon cancer AND resection

The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

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ClinicalTrials.gov Identifier: NCT03531606
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kye Bong-Hyeon, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Sigmoid Colon Cancer Drug: Mechnicov probiotics Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study has been designed for randomized, double Blinded, placebo clinical trial.
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
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 Name: 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 Name: Anterior resection




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531606


Locations
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Korea, Republic of
In Kyu Lee
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
Kye Bong-Hyeon
Investigators
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Study Director: SungSik Jang, Ph.D R &D

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Responsible Party: Kye Bong-Hyeon, Associate Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03531606     History of Changes
Other Study ID Numbers: KY_Mpro3
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Sigmoid Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Sigmoid Diseases