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
  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

Further study details as provided by Gangnam Severance Hospital:

Primary Outcome Measures:
  • endotoxin [ Time Frame: 1st visit and 3 weeks after 1st visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088087

Contacts
Contact: Jae Yong Shim, Master 82-02-2019-3155 hongbai96@yuhs.ac.kr
Contact: Hong Bae Kim, Bachelor 82-02-584-2823

Locations
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         
Sponsors and Collaborators
Gangnam Severance Hospital
Cell Biotech Co., Ltd.
Investigators
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 August 19, 2014