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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01088087
Collaborator
Cell Biotech Co., Ltd. (Industry)
34
Enrollment
1
Location
2
Arms
9
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: colostrum
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. endotoxin [1st visit and 3 weeks after 1st visit]

    Secondary Outcome Measures

    1. lactulose/mannitol ratio [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangnam Severance Hospital : Family medicine department Seoul Korea, Republic of

    Sponsors and Collaborators

    • Gangnam Severance Hospital
    • Cell Biotech Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01088087
    Other Study ID Numbers:
    • GangnamSH
    First Posted:
    Mar 17, 2010
    Last Update Posted:
    Mar 17, 2010
    Last Verified:
    Nov 1, 2009

    Study Results

    No Results Posted as of Mar 17, 2010