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Probiotic
Probiotic LGG for Alcoholic Liver Disease (AUD+ALD Trial)
Phase 2
Recruiting
Led By Vatsalya Vatsalya, MD PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of child-bearing potential must not be pregnant and must be using birth control
Age between 21 and 65 years old (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
AUD+ALD Trial Summary
This trialtests if LGG can improve Alcoholic Use Disorder (AUD) and Alcoholic Hepatitis (AH). It also looks at how LGG affects the gut-brain & inflammation.
Who is the study for?
This trial is for adults aged 21-65 with Alcohol Use Disorder and moderate Alcoholic Hepatitis. Participants must be heavy drinkers, have specific liver enzyme levels, not use drugs other than marijuana, and cannot be at high risk of suicide or on certain psychotropic meds. Pregnant women or those with severe medical conditions like cancer or cirrhosis are excluded.Check my eligibility
What is being tested?
The study tests if a 6-month course of Lactobacillus Rhamnosus GG (LGG), a probiotic, is more effective than a placebo in treating liver injury in patients with Alcohol Use Disorder and Alcoholic Hepatitis. It also examines the effects on gut-brain axis markers and inflammation.See study design
What are the potential side effects?
While the trial does not explicitly list side effects for LGG, common ones associated with probiotics include digestive discomfort such as gas or bloating. Since this involves patients with liver issues, monitoring for any unusual symptoms will be important.
AUD+ALD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and am using birth control.
Select...
I am between 21 and 65 years old.
Select...
I have been drinking heavily for the past 3 months.
AUD+ALD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
By lowering a biochemical marker of alcohol intake
By lowering heavy drinking to meet the criteria on the responder definitions of abstinence, no heavy drinking days, WHO 1-level, and WHO 2-level reduction
By reducing relapse episodes to minimal/absent incident level
+1 moreSecondary outcome measures
By lowering frequency and intensity of treatment/disease based adverse effects (AE).
By significantly improving liver related and clinical markers
By substantially improving the overall health as assessed by the patient reported outcomes
Other outcome measures
Exercise, Aerobic
AUD+ALD Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: Lactobacillus Rhamnosus GGActive Control1 Intervention
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Group II: Placebo Comparator: Placebo for ProbioticPlacebo Group1 Intervention
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,924 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,337 Total Patients Enrolled
423 Trials studying Alcoholism
985,648 Patients Enrolled for Alcoholism
Amar Sutrawe, MBBSStudy DirectorDepartment of Medicine, University of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I needed more than 2 blood transfusions due to stomach bleeding in the last 2 weeks.I do not have major health issues, except for moderate liver disease.I am not pregnant and am using birth control.I do not have active hepatitis B, tuberculosis, or HIV.I have been diagnosed with schizophrenia, bipolar disorder, or another psychosis, eating disorders; or major depression in the past year.I haven't taken naltrexone, acamprosate, topiramate, or disulfiram in the last month.I am currently taking medication for my mental health that I cannot stop.I have a history of significant low blood pressure episodes.My BMI is 33 or higher.I have had a fever over 38°C and been on antibiotics for more than 3 days recently due to an infection.I am between 21 and 65 years old.I am willing to undergo the treatment offered in the trial.I have been drinking heavily for the past 3 months.I have a serious medical condition like cancer, liver or heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Comparator: Placebo for Probiotic
- Group 2: Active Comparator: Lactobacillus Rhamnosus GG
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of individuals that are being treated in this experiment?
"Affirmative. The data on clinicaltrials.gov demonstrates that this investigation is currently recruiting participants, with the original posting dating back to February 1st 2023 and a subsequent revision occurring on November 8th 2022. 60 patients need to be enrolled at one centre for the trial's completion."
Answered by AI
Which individuals are permitted to register for this medical trial?
"To be eligible for the trial, individuals must have an alcohol use disorder and lie between 21-65 years old. We are currently enrolling a total of 60 patients who meet these criteria."
Answered by AI
Is enrollment open for this research initiative?
"Affirmative. According to clinicaltrials.gov, this trial is recruiting participants at the present time; it was initially published on February 1st 2023 and had its most recent update on November 8th 2022. The study needs 60 patients from a single site for inclusion in their research."
Answered by AI
Has the FDA confirmed the efficacy of Active Comparator: Lactobacillus Rhamnosus GG?
"There is a certain level of evidence for the safety profile of Active Comparator: Lactobacillus Rhamnosus GG, warranting it an assessment score of 2. Unfortunately, there are no clinical data to attest its efficacy."
Answered by AI
Are individuals aged 30 or over eligible to participate in this clinical research program?
"Based on the trial's enumerated requirements, individuals over 21 and under 65 are eligible to take part."
Answered by AI
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