Effects of Ethanol on Intestinal Permeability and Integrity
NCT ID: NCT00928733
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2009-09-30
2012-01-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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alcohol
Intraduodenal infusion of ethanol
Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Ethanol
Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Placebo
Intraduodenal infusion of tap water
Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Interventions
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Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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A Masclee, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht UMC
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
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References
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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. doi: 10.1136/gut.24.5.399.
Hirsch S, Chaves 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.
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. doi: 10.1152/ajpgi.00464.2004. Epub 2005 Feb 17.
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 16;9(9):e107421. doi: 10.1371/journal.pone.0107421. eCollection 2014.
Related Links
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Increased intestinal permeability
Other Identifiers
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09-3-026
Identifier Type: -
Identifier Source: org_study_id