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Effects of Ethanol on Intestinal Permeability and Integrity

The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00928733
Enrollment
17
Registered
2009-06-26
Start date
2009-09-30
Completion date
2012-01-31
Last updated
2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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.

Brief summary

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.

Interventions

DEVICEGastroduodenoscopy- Intraduodenal intubation

20 g ethanol diluted up to 10% in tap water

Sponsors

Top Institute Food and Nutrition
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.2 years

Secondary

MeasureTime frame
To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.2 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026