NCT01088087

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 17, 2010

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

March 16, 2010

Last Update Submit

March 16, 2010

Conditions

Leaky Gut Syndrome

Outcome Measures

Primary Outcomes (1)

  • endotoxin

    1st visit and 3 weeks after 1st visit

Secondary Outcomes (1)

  • lactulose/mannitol ratio

    3 weeks

Study Arms (2)

Colostrum

PLACEBO COMPARATOR
Dietary Supplement: colostrum

Sugar pill

NO INTERVENTION

Interventions

colostrumDIETARY_SUPPLEMENT

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

Also known as: Mucoba
Colostrum

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital : Family medicine department

Seoul, South Korea

RECRUITING

Study Officials

  • Jae Yong Shim, Master

    Gangnam Severance Hospital

    STUDY DIRECTOR

Central Study Contacts

Jae Yong Shim, Master

CONTACT

82-02-2019-3155hongbai96@yuhs.ac.kr

Hong Bae Kim, Bachelor

CONTACT

82-02-584-2823

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

March 17, 2010

Record last verified: 2009-11

Locations

KR(1)