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Completed

NCT Number: NCT05232682

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).

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Key information

Conditions

Alcohol; Use, Problem Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seed DS-01 Daily Synbiotic

Dietary Supplement

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

Primary outcomes

  1. Lipopolysaccharide Binding Protein (LBP)

    Time frame: 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

  2. Soluble Cluster of Differentiation 14 (sCD14)

    Time frame: 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

  3. Soluble Cluster of Differentiation 163 (sCD163)

    Time frame: 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

  4. Interleukin-6 (IL-6)

    Time frame: 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

  5. Monocyte Chemoattractant Protein-1 (MCP-1)

    Time frame: 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

  6. Tumor Necrosis Factor Alpha (TNF-a)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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