Effects of Ethanol on Intestinal Permeability and Integrity

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00928733
First received: June 25, 2009
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

Alcohol consumption is a major health problem worldwide. It affects all systems of the body especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious effects on the gastrointestinal mucosa vary from increased intestinal permeability, structural changes to sever destruction of the epithelial lining cells. Human data are still limited and most of the studies were performed in chronic alcohol abusers.

The investigators hypothesize that moderate alcohol drinking also may increase small intestinal permeability and contribute to the subsequent disruption of the tight junction complex. This study may provide more insight into the effects of moderate alcohol drinking on the small intestinal permeability.


Condition Intervention
Healthy
Device: Gastroduodenoscopy- Intraduodenal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alcohol
Intraduodenal infusion of ethanol
Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Ethanol Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Experimental: Placebo
Intraduodenal infusion of tap water
Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent form.
  • Male gender to avoid the gender-related differences in ethanol metabolism.
  • Between 18-45 years to avoid age-related changes in ethanol metabolism39.
  • Normal medical history and physical examination.
  • Normal liver function tests (i.e. ALT, AST, and γGT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University Medical Center.
  • Caucasian ethnicity.
  • BMI=18 - 30 kg/m2.

Exclusion Criteria:

  • History of gastro-intestinal disorders or abdominal surgery.
  • History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)40.
  • Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
  • Smoking.
  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: NCT00928733

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: A Masclee, MD PhD Maastricht UMC
  More Information

Additional Information:
Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00928733     History of Changes
Other Study ID Numbers: 09-3-026
Study First Received: June 25, 2009
Last Updated: May 16, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Permeability
tight junctions
cytokines
inflammatory bowel diseases
The effect of alcohol on the intestinal permeability may have major consequences on health.
It's generally accepted that an increased intestinal permeability in alcoholic subjects lead
to translocation of bacterial endotoxins from the gut lumen into the portal vein and then to the liver.
In the liver, endotoxins trigger the immune system and activate the resident macrophages, Kupffer cells.
Activation of Kupffer cells leads to production of chemokines (IL-8) and
proinflammatory cytokines (IL-1, TNFα),resulting in hepatocytes damage, inflammation, fibrosis and finally cirrhosis.

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014