Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- endotoxin [ Time Frame: 1st visit and 3 weeks after 1st visit ] [ Designated as safety issue: Yes ]
- lactulose/mannitol ratio [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Colostrum||
Dietary Supplement: colostrum
colostrum, 2g, 2 times a day, for 3 weeks
Other Name: Mucoba
|No Intervention: Sugar pill|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088087
|Korea, Republic of|
|Gangnam Severance Hospital : Family medicine department|
|Seoul, Korea, Republic of|
|Study Director:||Jae Yong Shim, Master||Gangnam Severance Hospital|