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Alcoholic Liver DiseaseEarly Phase 1NCT05428072

Alcohol, Gut Leakiness, & Liver Disease

A Early Phase 1 study testing Sugar test and Aspirin Challenge in people with Alcoholic Liver Disease, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Alcoholic Liver Disease
What is being tested?
Sugar test and Aspirin Challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteUnited States
Study dates
Jan 2003to Mar 2015
Phase
Early Phase 1
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • There are 4 different categories of participants that were used for recruitment:
  • Healthy controls
  • Subjects must have a normal physical exam
  • No GI complaints
  • No known liver disease
  • Normal liver function tests (ALT, AST, bilirubin, alkaline phosphatase, serum albumin)
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  • Consume no more than a moderate amount of alcohol (NIAAA definition [1 ]).
  • These subjects should not be daily drinkers (< 3x / week) and should typically drink < 3 drinks per occasion.
  • Alcoholics
  • Subjects should fulfill NIAAA criteria for at-risk drinking \& alcohol abuse or dependence \& DSM-IV criteria for alcoholism
  • Each must have consumed alcohol regularly for at least the past 3 mos but must be sober for 3-7 day post-binge at the time of sugar test (except for group 7)
  • Have a total regular heavy drinking history of at least 10 y (except for Group 6) the minimal period of time required for the development of ALD.
  • These are the different alcoholic groups and their specific inclusion criteria:
  • ALCOHOLICS WITHOUT LIVER DISEASE
  • no clinical evidence of ALD on physical examination
  • serum bilirubin or ALT or AST less than 1.25X normal
  • sobriety must be <7 days at the time of sugar test.
  • ALCOHOLICS WITH LIVER DISEASE
  • These subjects will have 1 of 3 possible grades of LD severity (mild, moderate, severe) \& have either clinical evidence of LD (hepatomegaly, splenomegaly, and esophageal varices), or serum bilirubin or ALT or AST more than 1.5X normal.
  • If liver biopsy or CT or ultrasound is available, there should be histological evidence of LD (alcoholic hepatitis or cirrhosis) or radiological evidence of LD (cirrhotic liver, splenomegaly, varices)
  • Their sobriety must be <7 days at the time of the sugar test.
  • ALCOHOLICS WITH SHORT-TERM Drinking
  • These subjects should fulfill the criteria of alcohol abuse
  • have sobriety <7 days at the time of urine collection, but the duration of their heavy drinking must be <5 years
  • They must not have any liver disease (negative serology) due to non-EtOH causes or clinical evidence of
  • cirrhosis. Here, liver enzyme levels are not inclusion/exclusion criteria; but since the duration of EtOH abuse (<5 y) is too short for the development of cirrhosis, it is expected that none will have sustained elevated liver enzymes.
  • SOBER ALCOHOLICS WITH LD .
  • Criteria is the same as Alcholics with liver disease but last drink was >7 days from the study enrollment.
  • Subjects with Non-alcoholic liver disease
  • Criteria for LD are similar to those outlined for alcoholics with liver disease subjects except that drinking history should be similar to that of healthy volunteers. Subjects after liver transplant.
  • These subjects must have successful liver transplantation at least 6 mos prior to the study and are on stable doses of immunosuppression for 3 mos.

Who cannot join

  • Unreliable drinking history (to rule out closet drinkers or pretenders).
  • Subjects must clearly fulfill the criteria either of "alcoholism" or of "on-drinker".
  • Subjects with a drinking history of 5-9 years duration are excluded since this period is not short enough to preclude cirrhosis nor long enough to cause ALD in most subjects.
  • Significant renal impairment (creatinine>l.2 mg/dL
  • Diseases that affect GI motility such as scleroderma.
  • insulin-requiring diabetes \&/or uncontrolled diabetes (Hgb-Alc>8%)
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  • Clinically significant dehydration.
  • clinically detectable ascites
  • Significant peripheral edema
  • Sepsis
  • Clinically significant cardiac failure
  • Regular daily use of medications that may affect intestinal permeability such as NSAIDS or intestinal motility (e.g. metoclopramide).
  • Alcoholics positive for other markers of LD such as smooth muscle antibody, hepatitis B surface antigen, hepatitis C antibody or hemochromatosis
  • Inability to sign an informed consent form
  • Patients with low platelet count (<80k), uncorrectable prolonged PT (>15 sec), history of bleeding will be excluded from aspirin tests

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ali Keshavarzian

    Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Being tested
Sugar test, Aspirin Challenge
Keywords
intestinal permeability
Medical subject headings
Liver Diseases, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugar testOther

    All participants will take two sugar tests ( sugar cocktail consisting of mannitol \& lactulose) subjects within 2-3 days of the initial sugar test.

  • Aspirin ChallengeDrug

    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.

Study groups in NCT05428072
Study groupRoleWhat they receive
sugar testExperimentalParticipants will undergo 3 sugar tests followed by
Receives: Other: Sugar test; Drug: Aspirin Challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in gut permeability

    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.

    Measured: 3 days

  2. Changes in gut permeability after consuming aspirin

    Participants will take will consume 2 doses of aspirin, 1.3 g each given at 12 \& 1 h before taking a sugar test. A urinary analysis was performed to measure the secretion of sugar and indicates gut permeability.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study startJan 2003
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05428072
Sponsor's protocol ID
ORA 09042105
Status last verified
Jun 2022
First submitted
16 Jun 2022
Last updated
22 Jun 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Swanson GR, Garg K, Shaikh M, Keshavarzian A. Increased Intestinal Permeability and Decreased Resiliency of the Intestinal Barrier in Alcoholic Liver Disease. Clin Transl Gastroenterol. 2024 Apr 1;15(4):e00689. doi: 10.14309/ctg.0000000000000689.

    PubMed 38334953

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Sugar test and Aspirin Challenge in people with Alcoholic Liver Disease, run by Rush University Medical Center at 1 site in United States.

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 31 inclusion and 15 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 22 Jun 2022. 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 United States. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Changes in gut permeability (time frame: 3 days). The study lists 2 primary outcomes in all. 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 NCT05428072, which also lists 1 linked publication.

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 22 Jun 2022.

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