Effects of Ethanol on Intestinal Permeability and Integrity
This study has been completed.
Sponsor:
Maastricht University Medical Center
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00928733
First received: June 25, 2009
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Device: Gastroduodenoscopy- Intraduodenal intubation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) |
| Official Title: | The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: alcohol
Intraduodenal infusion of ethanol
|
Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
|
| Ethanol |
Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
|
|
Experimental: Placebo
Intraduodenal infusion of tap water
|
Device: Gastroduodenoscopy- Intraduodenal intubation
20 g ethanol diluted up to 10% in tap water
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928733
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
| Principal Investigator: | A Masclee, MD PhD | Maastricht UMC |
More Information
Additional Information:
Publications:
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;125:653-8.
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00928733 History of Changes |
| Other Study ID Numbers: | 09-3-026 |
| Study First Received: | June 25, 2009 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
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. |
Additional relevant MeSH terms:
|
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013