Probiotics, Immune Function, and the Brain in Alcohol Consumers

Study Overview
=================
Brief Summary
-----------------
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).

Detailed 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.

Official Title
-----------------
Probiotics, Immune Function, and the Brain in Alcohol Consumers

Conditions
-----------------
Alcohol; Use, Problem

Intervention / Treatment
-----------------
* Dietary Supplement: Seed DS-01 Daily Synbiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, open label trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Arm<br>Probiotic arm | Dietary Supplement: Seed DS-01 Daily Synbiotic<br>* Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipopolysaccharide binding protein (LBP) | LBP levels in plasma | 30 days | 
| soluble cluster of differentiation 14 (sCD14) | sCD14 levels in plasma | 30 days | 
| soluble cluster of differentiation 163 (sCD163) | sCD163 levels in plasma | 30 days | 
| interleukin-6 (IL-6) | IL-6 levels in plasma | 30 days | 
| monocyte chemoattractant protein-1 (MCP-1) | MCP-1 levels in plasma | 30 days | 
| tumor necrosis factor alpha (TNF-a) | TNF-a levels in plasma | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol use, probiotics, heavy drinking, brain, immune function