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Status unknownNCT01088087Updated Mar 17, 2010

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

A Phase 2/3 interventional study of colostrum in Leaky Gut Syndrome, sponsored by Gangnam Severance Hospital. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-17.

Sponsored by Gangnam Severance Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Leaky Gut Syndrome
03

In context

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (estimated)

Study arms

  • Placebo comparator
    Colostrum

    Dietary Supplement: colostrum

  • No intervention
    Sugar pill

Interventions

  • Dietary supplementcolostrum

    colostrum, 2g, 2 times a day, for 3 weeks

    Also known as: Mucoba

06

What researchers measure

Primary outcomes

  1. endotoxin

    Time frame: 1st visit and 3 weeks after 1st visit

Secondary outcomes

  1. lactulose/mannitol ratio

    Time frame: 3 weeks

07

Study locations

1 of 1 sites recruiting
  • Gangnam Severance Hospital : Family medicine department
    Seoul, Korea, Republic of
    • Jae Yong Shim, Master · Contact · hongbai96@yuhs.ac.kr · 82-02-2019-3155
    • Hong Bae Kim, Bachelor · Contact · 82-02-584-2823
    • Hong Bae Kim, Bacholer · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01088087
Lead sponsor
Gangnam Severance Hospital
Collaborators
Cell Biotech Co., Ltd.
First posted
Mar 17, 2010
Start date
Mar 2010
Primary completion
Sep 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Mar 17, 2010

Study contacts

Jae Yong Shim, Master
Contact
hongbai96@yuhs.ac.kr
82-02-2019-3155
Hong Bae Kim, Bachelor
Contact
82-02-584-2823
Jae Yong Shim, Master
study director · Gangnam Severance Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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