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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088087

Enrollment

Registered

2010-03-17

Start date

2010-03-31

Completion date

2010-12-31

Last updated

2010-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leaky Gut Syndrome

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.

Interventions

DIETARY_SUPPLEMENTcolostrum

colostrum, 2g, 2 times a day, for 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
endotoxin	1st visit and 3 weeks after 1st visit

Secondary

Measure	Time frame
lactulose/mannitol ratio	3 weeks

Countries

South Korea

Contacts

Primary ContactJae Yong Shim, Master

hongbai96@yuhs.ac.kr82-02-2019-3155

Backup ContactHong Bae Kim, Bachelor

82-02-584-2823

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026