Effects of Ethanol on Intestinal Permeability and Integrity

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Gastroduodenoscopy- Intraduodenal intubation

• Registration Number: NCT00928733
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Start: 2009-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
alcohol	Gastroduodenoscopy- Intraduodenal intubation	Intraduodenal infusion of ethanol
Ethanol	Gastroduodenoscopy- Intraduodenal intubation	-
Placebo	Gastroduodenoscopy- Intraduodenal intubation	Intraduodenal infusion of tap water

Primary Outcome Measures

Name	Time	Method
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.	2 years

Secondary Outcome Measures

Name	Time	Method
To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.	2 years

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands