Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- endotoxin
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Colostrum
Intervention: colostrum (Dietary Supplement)
Sugar pill
Outcomes
Primary Outcomes
endotoxin
Time Frame: 1st visit and 3 weeks after 1st visit
Secondary Outcomes
- lactulose/mannitol ratio(3 weeks)