The study aims to investigate the effects of moderate ethanol drinking on the intestinal permeability and the tight junction complex. If there increase in the intestinal permeability, these effects will be investigated at molecular level.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is to assess the small intestinal permeability by means of
sugar permeability testing after intraduodenal administration of ethanol.
Secondary outcome
The secondary outcomes are assessing tight junctions structure in the biopsy
specimens, measuring serum and mucosal ethanol and acetaldehyde concentrations.
Ex vivo determination of the effect of ethanol and acetaldehyde on tight
junction functionality using Ussing chambers
Background 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.
We 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 objective
The study aims to investigate the effects of moderate ethanol drinking on the
intestinal permeability and the tight junction complex. If there increase in
the intestinal permeability, these effects will be investigated at molecular
level.
Study design
This study is a placebo-controlled study.
Intervention
During this study, alcohol will be administered intraduodenally to induce
changes in the intestinal permeability. The exact dose of ethanol will be
determined in the pilot study
Study burden and risks
The possible risks in the study are related to the effects of ethanol on the
nervous system such nausea , vomiting and euphoria. There are also possible
risks related to the intervention with the gastroduodenoscope e.g the risks of
bleeding at the site of the biopsy and perforation of the viscera.
PO Box 616
6200MD Maastricht
Nederland
PO Box 616
6200MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- Signed informed consent
- Male gender
- Age between 18 and 45 years
- Normal medical history and physical examination
- Normal liver function tests
- Caucausian ethnicity
- BMI between 18 and 30
Exclusion criteria
- History of gastrointestinal disorders or abdominal surgery (uncomplicated appendectomy and cholecystectomy allowed, other surgery upon judgement of the principal investigator)
- History of alcohol abuse or current excessive alcolhol 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
- Smoking
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27994.068.09 |