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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Gangnam Severance Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cell Biotech Co., Ltd.
Information provided by:
Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01088087
First received: March 16, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted

March 16, 2010
March 16, 2010
March 2010
September 2010   (final data collection date for primary outcome measure)
endotoxin [ Time Frame: 1st visit and 3 weeks after 1st visit ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
lactulose/mannitol ratio [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Leaky Gut Syndrome
Dietary Supplement: colostrum
colostrum, 2g, 2 times a day, for 3 weeks
Other Name: Mucoba
  • Placebo Comparator: Colostrum
    Intervention: Dietary Supplement: colostrum
  • No Intervention: Sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Male
20 Years and older
Yes
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
 
NCT01088087
GangnamSH
Yes
Yonsei University, Gangnam Severance Hospital
Gangnam Severance Hospital
Cell Biotech Co., Ltd.
Study Director: Jae Yong Shim, Master Gangnam Severance Hospital
Gangnam Severance Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP