Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease

March 16, 2010 updated by: Gangnam Severance Hospital

Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction

Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome.

So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We randomly sort the participant as placebo group and colostrum group. Each group consists of 17 people. and the duration of our study for one participant is 3 weeks. (Participant takes colostrum for 3 weeks.)

When a person gets leaky gut syndrome, his or her endotoxin and lactulose/mannitol ratio (L/M ratio, in urine) can elevate.

So We will compare the value of those two parameters and LFT. etc. after the administration of colostrum or placebo.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Hong Bae Kim, Bachelor
  • Phone Number: 82-02-584-2823

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital : Family medicine department
        • Contact:
        • Contact:
          • Hong Bae Kim, Bachelor
          • Phone Number: 82-02-584-2823
        • Sub-Investigator:
          • Hong Bae Kim, Bacholer

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men aged over 20 who's alcohol consumption per day is 20.0gram average

    • He must agree to participate this trial voluntarily.
  • Liver function test within 3 months :

AST more than 30 or ALT more than 33 or Gamma-GT more than 46

  • Men who have result of Ultra-sono result of abdomen without Liver cirrhosis

Exclusion Criteria:

  • Hepatitis B or C , liver cirrhosis patient
  • Men who have undergo bowel operation
  • Men who are taking NSAIDs
  • Periodontitis or GERD or other G-I tract infection within 2 weeks before enrollment
  • Men who have been given anticancer drug within one year
  • Men who have been given antibiotics within 2 weeks
  • Creatinine level >= 1.4mg/dl
  • Men who are taking G-I motility drugs or anti-ulcer drug
  • Milk allergy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Colostrum
Dietary supplement: colostrum
colostrum, 2g, 2 times a day, for 3 weeks
Other Names:
  • Mucoba
No Intervention: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endotoxin
Time Frame: 1st visit and 3 weeks after 1st visit
1st visit and 3 weeks after 1st visit

Secondary Outcome Measures

Outcome Measure
Time Frame
lactulose/mannitol ratio
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

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

Sponsor

Gangnam Severance Hospital

Collaborators

Cell Biotech Co., Ltd.

Investigators

  • Study Director: Jae Yong Shim, Master, Gangnam Severance Hospital

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

March 1, 2010

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2010

Last Update Submitted That Met QC Criteria

March 16, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • GangnamSH

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.

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