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CompletedNCT00928733Updated Nov 13, 2014

Effects of Ethanol on Intestinal Permeability and Integrity

An interventional study of Gastroduodenoscopy- Intraduodenal intubation in Healthy, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Maastricht University Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Permeability
  • tight junctions
  • cytokines
  • inflammatory bowel diseases
  • The effect of alcohol on the intestinal permeability may have major consequences on health.
  • It's generally accepted that an increased intestinal permeability in alcoholic subjects lead
  • to translocation of bacterial endotoxins from the gut lumen into the portal vein and then to the liver.
  • In the liver, endotoxins trigger the immune system and activate the resident macrophages, Kupffer cells.
  • Activation of Kupffer cells leads to production of chemokines (IL-8) and
  • proinflammatory cytokines (IL-1, TNFα),resulting in hepatocytes damage, inflammation, fibrosis and finally cirrhosis.
03

In context

Inflammatory Bowel Diseases

1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.

This study's enrollment of 17 is below the median of 70 across 783 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

Browse Maastricht University Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    alcohol

    Intraduodenal infusion of ethanol

    Device: Gastroduodenoscopy- Intraduodenal intubation

  • Other
    Ethanol

    Device: Gastroduodenoscopy- Intraduodenal intubation

  • Experimental
    Placebo

    Intraduodenal infusion of tap water

    Device: Gastroduodenoscopy- Intraduodenal intubation

Interventions

  • DeviceGastroduodenoscopy- Intraduodenal intubation

    20 g ethanol diluted up to 10% in tap water

06

What researchers measure

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

07

Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, Limburg 6202 AZ, Netherlands
08

References and documents

Publications

  • 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. PubMed 6840613 ↗
  • 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. PubMed 9515283 ↗
  • 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. PubMed 15718285 ↗
  • 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. PubMed 25226407 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2009
First posted
Jun 26, 2009
Start
Sep 2009
Primary completionActual
Jan 2012
CompletionActual
Jan 2012
Last update
Nov 13, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00928733
Lead sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
Responsible party
Sponsor
First posted
Jun 26, 2009
Start date
Sep 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Nov 13, 2014

Study contacts

A Masclee, MD PhD
principal investigator · Maastricht UMC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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