Probiotics, Immune Function, and the Brain in Alcohol Consumers

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).

Study Overview

• Status: Completed
• Conditions: Alcohol; Use, Problem
• Intervention / Treatment: Dietary supplement: Seed DS-01 Daily Synbiotic

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Mollie Monnig, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; brain; immune function; alcohol use; heavy drinking
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2109003092; P01AA019072 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No