What is the mechanism of action of this treatment?

Common treatments for Alcoholism, such as the use of probiotics like Lactobacillus rhamnosus GG (LGG), work by modulating the gut microbiota, which can influence the gut-brain axis and inflammatory responses. This modulation helps reduce gut permeability and systemic inflammation, which are often exacerbated by alcohol consumption. By improving gut health and reducing inflammation, these treatments can alleviate some of the neuropsychiatric symptoms associated with Alcohol Use Disorder (AUD), offering a holistic approach that addresses both the physical and mental health challenges faced by patients with Alcoholism.

What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like disulfiram, naltrexone, and acamprosate, which can have side effects such as nausea, headache, dizziness, and liver toxicity. Probiotics like Lactobacillus rhamnosus GG (LGG), which are being studied for their potential to modulate gut microbiota and inflammatory responses in alcoholism, are generally considered safe but can sometimes cause mild gastrointestinal symptoms such as gas, bloating, and diarrhea. The safety of commercially available probiotic products can be uncertain due to potential contamination and variability in product content.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, including disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, naltrexone blocks the euphoric effects and feelings of intoxication, and acamprosate helps reduce cravings and withdrawal symptoms. While these treatments do not specifically target gut microbiota or the gut-brain axis, they represent the primary pharmacological approaches approved by the FDA. Probiotics like Lactobacillus rhamnosus GG, which are being studied for their potential to modulate gut microbiota and inflammatory responses, are not yet FDA-approved for the treatment of alcoholism.

What other types of research exist?

Promising alternatives to LGG for alcoholism patients include Lactobacillus reuteri DSM 17938, which has shown efficacy in modulating gut microbiota and inflammatory responses, and Bifidobacterium breve M-16V, which has demonstrated benefits in gut health and immune modulation. These probiotics could be considered for their potential therapeutic effects in treating alcoholism.

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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)

Must not have

Acute gastrointestinal bleeding requiring > 2 units blood transfusion within the previous 2 weeks

Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Summary

This trial tests if taking a probiotic called LGG for several months can help people with heavy drinking and liver damage. The study aims to see if LGG can reduce drinking, improve liver health, and lower inflammation by improving gut health. LGG has been shown to improve intestinal barrier function and alleviate liver injury induced by alcohol consumption in animal models.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and am using birth control.

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I am between 21 and 65 years old.

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I have been drinking heavily for the past 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I needed more than 2 blood transfusions due to stomach bleeding in the last 2 weeks.

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I do not have major health issues, except for moderate liver disease.

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I do not have active hepatitis B, tuberculosis, or HIV.

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I have been diagnosed with schizophrenia, bipolar disorder, or another psychosis, eating disorders; or major depression in the past year.

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I am currently taking medication for my mental health that I cannot stop.

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I have a history of significant low blood pressure episodes.

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My BMI is 33 or higher.

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I have had a fever over 38°C and been on antibiotics for more than 3 days recently due to an infection.

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I have a serious medical condition like cancer, liver or heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 study objectives

Exercise, Aerobic

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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alcoholism, such as the use of probiotics like Lactobacillus rhamnosus GG (LGG), work by modulating the gut microbiota, which can influence the gut-brain axis and inflammatory responses. This modulation helps reduce gut permeability and systemic inflammation, which are often exacerbated by alcohol consumption. By improving gut health and reducing inflammation, these treatments can alleviate some of the neuropsychiatric symptoms associated with Alcohol Use Disorder (AUD), offering a holistic approach that addresses both the physical and mental health challenges faced by patients with Alcoholism.