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

Leaky Gut Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01088087
• Other study ID #: GangnamSH
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 16, 2010
• Last updated: March 16, 2010
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Gangnam Severance Hospital
• Contact: Jae Yong Shim, Master
• Phone: 82-02-2019-3155
• Email: hongbai96[@]yuhs.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leaky Gut Syndrome

Intervention

Dietary Supplement:
• colostrum
colostrum, 2g, 2 times a day, for 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital : Family medicine department	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Gangnam Severance Hospital	Cell Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endotoxin		1st visit and 3 weeks after 1st visit	Yes
Secondary	lactulose/mannitol ratio		3 weeks	Yes