Effects of Ethanol on Intestinal Permeability and Integrity

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928733
• Other study ID #: 09-3-026
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: November 11, 2014
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: November 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 ?GT) 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Basuroy S, Sheth P, Mansbach CM, Rao RK. Acetaldehyde disrupts tight junctions and adherens junctions in human colonic mucosa: protection by EGF and L-glutamine. Am J Physiol Gastrointest Liver Physiol. 2005 Aug;289(2):G367-75. Epub 2005 Feb 17. — View Citation

Draper LR, Gyure LA, Hall JG, Robertson D. Effect of alcohol on the integrity of the intestinal epithelium. Gut. 1983 May;24(5):399-404. — View Citation

Elamin E, Masclee A, Troost F, Pieters HJ, Keszthelyi D, Aleksa K, Dekker J, Jonkers D. Ethanol impairs intestinal barrier function in humans through mitogen activated protein kinase signaling: a combined in vivo and in vitro approach. PLoS One. 2014 Sep — View Citation

Hirsch S, Cháves G, Gotteland M, de la Maza P, Petermann M, Barrera P, Bunout D. [Intestinal permeability in alcoholic patients without liver damage]. Rev Med Chil. 1997 Jun;125(6):653-8. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.		2 years	Yes
Secondary	To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.		2 years	Yes

External Links

•   Increased intestinal permeability