Probiotics, Immune Function, and the Brain in Alcohol Consumers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2023-08-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alcohol; Use, Problem

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group, open label trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Probiotic Arm

Probiotic arm

Group Type EXPERIMENTAL

Seed DS-01 Daily Synbiotic

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Seed DS-01 Daily Synbiotic

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes