NCT05428072

Alcohol, Gut Leakiness, & Liver Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate the role of gut leakiness in alcoholic liver disease. Gut leakiness may be the missing susceptibility factor that explains why some alcoholics develop liver disease and others don't. For this study, subjects 480 (240 male, 240 female, ages 18-80) will be recruited. Alcoholic subjects will be recruited from outpatient \& inpatient alcohol detoxification units from Rush, Loyola \& two halfway houses (one for women, one for men); patients with liver disease from GI/Hepatology Services at Rush, Hines VA Hosp \& Loyola University; and controls from hospital staffs. All subjects will fill out a detailed questionnaire, be interviewed by the study coordinator \& undergo an exam by the PI to ensure that all inclusion criteria are satisfied. All subjects will have a urine collection for tests of intestinal permeability (urinary sugars). Gut leakiness will be determined by the amount of sugars in the urine.

Conditions

• Alcoholic Liver Disease

Interventions

Type	Name	Description
OTHER	Sugar test	All participants will take two sugar tests ( sugar cocktail consisting of mannitol \& lactulose) subjects within 2-3 days of the initial sugar test.
DRUG	Aspirin Challenge	All participants will take a sugar test after 2 doses of aspirin, 1.3 g each given at 12 \& 1 hour before the sugar drink.

Timeline

• Start date: 2003-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study