Probiotics, Immune Function, and the Brain in Alcohol Consumers

Alcohol; Use, Problem Clinical Trial

Official title:

Probiotics, Immune Function, and the Brain in Alcohol Consumers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232682
• Other study ID #: 2109003092
• Secondary ID: P01AA019072
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: August 9, 2023

Study information

• Verified date: April 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 9, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol; Use, Problem

Intervention

Dietary Supplement:
• Seed DS-01 Daily Synbiotic
Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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