The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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 metabolism
- •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)
- •Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
Arms & Interventions
alcohol
Intraduodenal infusion of ethanol
Intervention: Gastroduodenoscopy- Intraduodenal intubation (Device)
Ethanol
Intervention: Gastroduodenoscopy- Intraduodenal intubation (Device)
Placebo
Intraduodenal infusion of tap water
Intervention: Gastroduodenoscopy- Intraduodenal intubation (Device)
Outcomes
Primary Outcomes
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
Time Frame: 2 years
Secondary Outcomes
- To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.(2 years)