Leaky Gut SyndromePhase 2/3NCT01088087
Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease
A Phase 2/3 study testing colostrum in people with Leaky Gut Syndrome, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Leaky Gut Syndrome
- What is being tested?
- colostrum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Creatinine level >= 1.4mg/dl
- Men who are taking G-I motility drugs or anti-ulcer drug
- Milk allergy
Trial locations and contacts
1 site in 1 country.
Hong Bae Kim, Bachelor contact
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital : Family medicine department
Seoul
Jae Yong Shim, Master, 82-02-2019-3155, hongbai96@yuhs.ac.kr
Hong Bae Kim, Bachelor, 82-02-584-2823
About this study
Official title: 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.
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.
- Conditions
- Leaky Gut Syndrome
- Being tested
- colostrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colostrumDietary supplement
Also called Mucoba
colostrum, 2g, 2 times a day, for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Colostrum | Placebo comparator | Not described Receives: Dietary Supplement: colostrum |
| Sugar pill | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
endotoxin
Measured: 1st visit and 3 weeks after 1st visit
Secondary outcomes (1)
lactulose/mannitol ratio
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leaky Gut SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cell Biotech Co., Ltd.
- Investigators
- Jae Yong Shim, Master, Study director, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088087
- Sponsor's protocol ID
- GangnamSH
- Status last verified
- Nov 2009
- First submitted
- 16 Mar 2010
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction
- ClinicalTrials.gov ID
- NCT01088087
- Acronym / sponsor ID
- GangnamSH
- Conditions
- Leaky Gut Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Cell Biotech Co., Ltd.
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum | Placebo comparator | Dietary Supplement: colostrum |
| Sugar pill | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men aged over 20 who's alcohol consumption per day is 20.0gram average
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colostrumAlso: Mucobacolostrum, 2g, 2 times a day, for 3 weeks | Dietary supplement | Colostrum |
Primary outcome
endotoxin
Time frame: 1st visit and 3 weeks after 1st visit
1 secondary outcome
lactulose/mannitol ratio
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Bae Kim, Bachelor contact
Jae Yong Shim, Master study director
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing colostrum in people with Leaky Gut Syndrome, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Yong Shim, Master (82-02-2019-3155, hongbai96@yuhs.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endotoxin (time frame: 1st visit and 3 weeks after 1st visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2010.