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Effects of Ethanol on Intestinal Permeability and Integrity

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Healthy

Treatments

Device: Gastroduodenoscopy- Intraduodenal intubation

Study type

Interventional

Funder types

Other

Identifiers

NCT00928733
09-3-026

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

17 participants in 3 patient groups

alcohol
Experimental group
Description:
Intraduodenal infusion of ethanol
Treatment:
Device: Gastroduodenoscopy- Intraduodenal intubation
Ethanol
Other group
Treatment:
Device: Gastroduodenoscopy- Intraduodenal intubation
Placebo
Experimental group
Description:
Intraduodenal infusion of tap water
Treatment:
Device: Gastroduodenoscopy- Intraduodenal intubation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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