HealthyNCT00928733
Effects of Ethanol on Intestinal Permeability and Integrity
A study testing Gastroduodenoscopy- Intraduodenal intubation in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gastroduodenoscopy- Intraduodenal intubation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
Official title: The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals
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.
- Conditions
- Healthy
- Being tested
- Gastroduodenoscopy- Intraduodenal intubation
- 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.
- Medical subject headings
- Inflammatory Bowel Diseases, Inflammation, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastroduodenoscopy- Intraduodenal intubationDevice
20 g ethanol diluted up to 10% in tap water
| Study group | Role | What they receive |
|---|---|---|
| alcohol | Experimental | Intraduodenal infusion of ethanol Receives: Device: Gastroduodenoscopy- Intraduodenal intubation |
| Ethanol | Other | Not described Receives: Device: Gastroduodenoscopy- Intraduodenal intubation |
| Placebo | Experimental | Intraduodenal infusion of tap water Receives: Device: Gastroduodenoscopy- Intraduodenal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
Measured: 2 years
Secondary outcomes (1)
To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- A Masclee, MD PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928733
- Sponsor's protocol ID
- 09-3-026
- Status last verified
- Nov 2014
- First submitted
- 25 Jun 2009
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 6840613Hirsch 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 9515283Basuroy 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 15718285Elamin 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ethanol on Intestinal Permeability and Integrity in Healthy Individuals
- ClinicalTrials.gov ID
- NCT00928733
- Acronym / sponsor ID
- 09-3-026
- Conditions
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alcohol | Experimental | Device: Gastroduodenoscopy- Intraduodenal intubationIntraduodenal infusion of ethanol |
| Ethanol | Other | Device: Gastroduodenoscopy- Intraduodenal intubation |
| Placebo | Experimental | Device: Gastroduodenoscopy- Intraduodenal intubationIntraduodenal infusion of tap water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastroduodenoscopy- Intraduodenal intubation20 g ethanol diluted up to 10% in tap water | Device | Ethanol, Placebo, alcohol |
Primary outcome
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol.
Time frame: 2 years
1 secondary outcome
To assess tight junctions structure and proteins in biopsy specimens after intraduodenal administration of ethanol.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 6840613Draper 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.
- Background: PubMed 9515283Hirsch 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.
- Background: PubMed 15718285Basuroy 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.
- Results publication: PubMed 25226407Elamin 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.
- Increased intestinal permeabilityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Masclee, MD PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastroduodenoscopy- Intraduodenal intubation in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess intestinal permeability by means of sugar permeability testing after intraduodenal administration of ethanol. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928733, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.