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New treatment option for Alcohol Use Disorder
Official title LGG Supplementation in Patients With AUD and ALD
ClinicalTrials.gov ID: NCT05178069
What this study is testing
- What it's testing
- To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH). And to evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of the gut-brain axis and pro-inflammatory activity in patients with AUD and moderate AH
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
- Age between 21 and 65 years old (inclusive).
- Willingness to receive trial treatment.
- Ability to provide informed consent
- Understanding that this is not an alcohol treatment study.
You likely can't join if
- Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,
- Positive urine drug screen at baseline for any illegal substance other than marijuana,
- History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,
- Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,
- Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,
- Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis...
See the full eligibility criteria
- Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
- Age between 21 and 65 years old (inclusive).
- Willingness to receive trial treatment.
- Ability to provide informed consent
- Understanding that this is not an alcohol treatment study.
- Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.
- Diagnosis of Alcohol Use Disorder using DSM V criteria.
- 50 \ ALT; and ALT \ 1.2 mg/dL
- Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.
- Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.
- Provide contact information for someone who may be able to contact the subject in case of a missed appointment.
- . Females of child-bearing potential must not be pregnant and must be using birth control
- Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,
- Positive urine drug screen at baseline for any illegal substance other than marijuana,
- History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,
- Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,
- Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,
- Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression
- In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months),
- Current use of psychotropic medications that cannot be discontinued,
- Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19),
- Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) \>10, at screening for more than 3 days,
- Serious medical diseases, such as cancer, liver cirrhosis, pancreatitis, severe alcohol associated hepatitis, heart chronic failure, chronic kidney failure, chronic intestinal diseases (e.g., Crohn's disease), chronic...
- History of clinically significant hypotension (e.g., history of lipotimia and/or syncopal episodes)
- History of adverse reactions to needle puncture,
- Obesity (BMI ≥ 33.0 kg/m2),
- Pregnancy; incarceration; inability to provide consent
- Signs of systemic infection: Fever \> 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for \> 3 days within 3 days of inclusion
- Acute gastrointestinal bleeding requiring \> 2 units blood transfusion within the previous 2 weeks
- Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.