Probiotics, Immune Function, and the Brain in Alcohol Consumers

Brown University

Status and phase

Completed

Phase 2

Conditions

Alcohol; Use, Problem

Treatments

Dietary Supplement: Seed DS-01 Daily Synbiotic

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05232682

P01AA019072 (U.S. NIH Grant/Contract)

2109003092

Details and patient eligibility

About

This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).

Full description

This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease also may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit 15 non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1 is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy drinkers.

Enrollment

32 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18-64 years old;
Able to speak and read English well enough to complete study procedures;
Meets NIAAA guidelines for heavy drinking in the past 30 days.

Exclusion criteria

Chronic disease requiring daily use of medication;
Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
Self-reported history of liver disease;
Antibiotic or probiotic use in past 1 month;
Positive urine drug test;
History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
Safety contraindication for MRI (e.g., ferromagnetic implant in the body, claustrophobia);
Head trauma with loss of consciousness >10 min;
Pregnant, breastfeeding, or not using effective birth control;
Unable to complete the study visits due to time or scheduling constraints;
Weight <110 lbs.
Conditions of immunodeficiency, such as HIV infection, primary immune deficiency, or taking immune-suppressant medications.