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NCT Number: NCT00928733

Effects of Ethanol on Intestinal Permeability and Integrity

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.

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Key information

Conditions

Healthy Digestive System Diseases Fibrosis Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastroduodenoscopy- Intraduodenal intubation

Device

20 g ethanol diluted up to 10% in tap water

Primary outcomes

  1. To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.

    Time frame: 2 years

Secondary outcomes

  1. To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 26, 2009
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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