Probiotics, Immune Function, and the Brain in Alcohol Consumers

Phase 2

Completed

• Conditions: Alcohol; Use, Problem
• Interventions: Dietary Supplement: Seed DS-01 Daily Synbiotic

• Registration Number: NCT05232682
• Lead Sponsor: Brown University

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-02-24
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic Arm	Seed DS-01 Daily Synbiotic	Probiotic arm

Primary Outcome Measures

Name	Time	Method
Lipopolysaccharide Binding Protein (LBP)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	LBP levels in plasma
Soluble Cluster of Differentiation 14 (sCD14)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	sCD14 levels in plasma
Soluble Cluster of Differentiation 163 (sCD163)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	sCD163 levels in plasma
Interleukin-6 (IL-6)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	IL-6 levels in plasma
Monocyte Chemoattractant Protein-1 (MCP-1)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	MCP-1 levels in plasma
Tumor Necrosis Factor Alpha (TNF-a)	30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.	TNF-a levels in plasma

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States