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NCT05428072 · ClinicalTrials.gov registry record · Early Phase 1
Alcohol, Gut Leakiness, & Liver Disease
A Early Phase 1 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 195
- Enrollment target
NCT05428072: Completed Early Phase 1 study, sponsored by Rush University Medical Center.
NCT05428072 is a Early Phase 1 study that has completed, run by Rush University Medical Center. The registered enrollment target is 195 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428072, a Early Phase 1 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 195 participants
- Enrollment target
Study 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.
Primary Outcome
All participants will consume a sugar cocktail (lactulose \& mannitol) and collect their urine. A urinary analysis was performed to measure the secretion of sugar and indicates gut permeability.
Interventions
- DRUG Aspirin Challenge
- OTHER Sugar test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2003-01 |
| Est. Completion | 2015-03 |
| Phase | Early Phase 1 |
What the finished NCT05428072 record still lists
NCT05428072 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (268% higher).
The record links to 0 conditions, and to 2 interventions - of which Aspirin Challenge is the first listed.
NCT05428072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05428072 about?
NCT05428072 is a clinical study titled "Alcohol, Gut Leakiness, & Liver Disease". 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 recr...
What is the current status of trial NCT05428072?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 195 participants. The study started on 2003-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT05428072?
The interventions under investigation include: Aspirin Challenge (DRUG), Sugar test (OTHER).
Who is sponsoring clinical trial NCT05428072?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05428072's enrollment target sits among peer trials
195 70th of 2000 higher than 1,931 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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