Probiotics, Immune Function, and the Brain in Alcohol Consumers

Sponsor

Brown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05232682

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

100

Enrollment

Location

Arm

5.2

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol; Use, Problem	Dietary Supplement: Seed DS-01 Daily Synbiotic	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group, open label trialSingle group, open label trial

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Probiotics, Immune Function, and the Brain in Alcohol Consumers

Actual Study Start Date :

Feb 24, 2022

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Arm Probiotic arm	Dietary Supplement: Seed DS-01 Daily Synbiotic Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)

Arm

Intervention/Treatment

Experimental: Probiotic Arm

Probiotic arm

Dietary Supplement: Seed DS-01 Daily Synbiotic

Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.