Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leaky Gut Syndrome |
Dietary Supplement: colostrum |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 34 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Colostrum |
Dietary Supplement: colostrum
colostrum, 2g, 2 times a day, for 3 weeks
Other Name: Mucoba
|
| No Intervention: Sugar pill |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | 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
Contacts and Locations| Contact: Jae Yong Shim, Master | 82-02-2019-3155 | hongbai96@yuhs.ac.kr |
| Contact: Hong Bae Kim, Bachelor | 82-02-584-2823 |
| Korea, Republic of | |
| Gangnam Severance Hospital : Family medicine department | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Jae Yong Shim, Master 82-02-2019-3155 hongbai96@yuhs.ac.kr | |
| Contact: Hong Bae Kim, Bachelor 82-02-584-2823 | |
| Sub-Investigator: Hong Bae Kim, Bacholer | |
| Study Director: | Jae Yong Shim, Master | Gangnam Severance Hospital |
More Information
No publications provided
| Responsible Party: | Yonsei University, Gangnam Severance Hospital |
| ClinicalTrials.gov Identifier: | NCT01088087 History of Changes |
| Other Study ID Numbers: | GangnamSH |
| Study First Received: | March 16, 2010 |
| Last Updated: | March 16, 2010 |
| Health Authority: | Korea: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013