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

Y

Yonsei University Health System (YUHS)

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Leaky Gut Syndrome

Treatments

Dietary Supplement: colostrum

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01088087
GangnamSH

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

Male

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups, including a placebo group

Colostrum
Placebo Comparator group
Treatment:
Dietary Supplement: colostrum
Sugar pill
No Intervention group

Trial contacts and locations

1

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Central trial contact

Hong Bae Kim, Bachelor; Jae Yong Shim, Master

Data sourced from clinicaltrials.gov

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