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

Phase 2

• Conditions: Leaky Gut Syndrome
• Interventions: Dietary Supplement: colostrum

• Registration Number: NCT01088087
• Lead Sponsor: Gangnam Severance Hospital

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.

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 Timeline

• Status Verified: 2009-11
• Study Start: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Last Update Submitted: 2010-03-16
• Study First Posted: 2010-03-17
• Last Update Posted: 2010-03-17
• Primary Completion: 2010-09
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum	colostrum	-

Primary Outcome Measures

Name	Time	Method
endotoxin	1st visit and 3 weeks after 1st visit

Secondary Outcome Measures

Name	Time	Method
lactulose/mannitol ratio	3 weeks

Trial Locations

Locations (1)

Gangnam Severance Hospital : Family medicine department; 🇰🇷 Seoul, Korea, Republic of