LGG Supplementation in Patients With AUD and ALD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Louisville
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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,
Trial design
Treatments tested in this trial
- : Placebo for Probiotic
- Lactobacillus Rhamnosus GG
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Louisville
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov