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Probiotics, Immune Function, and the Brain in Alcohol Consumers

Primary Purpose

Alcohol; Use, Problem

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Seed DS-01 Daily Synbiotic
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol; Use, Problem focused on measuring alcohol use, probiotics, heavy drinking, brain, immune function

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic Arm

Arm Description

Probiotic arm

Outcomes

Primary Outcome Measures

lipopolysaccharide binding protein (LBP)
LBP levels in plasma
soluble cluster of differentiation 14 (sCD14)
sCD14 levels in plasma
soluble cluster of differentiation 163 (sCD163)
sCD163 levels in plasma
interleukin-6 (IL-6)
IL-6 levels in plasma
monocyte chemoattractant protein-1 (MCP-1)
MCP-1 levels in plasma
tumor necrosis factor alpha (TNF-a)
TNF-a levels in plasma

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
June 1, 2023
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05232682
Brief Title
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Official Title
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Use, Problem
Keywords
alcohol use, probiotics, heavy drinking, brain, immune function

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single group, open label trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Arm
Arm Type
Experimental
Arm Description
Probiotic arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Seed DS-01 Daily Synbiotic
Intervention Description
Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
Primary Outcome Measure Information:
Title
lipopolysaccharide binding protein (LBP)
Description
LBP levels in plasma
Time Frame
30 days
Title
soluble cluster of differentiation 14 (sCD14)
Description
sCD14 levels in plasma
Time Frame
30 days
Title
soluble cluster of differentiation 163 (sCD163)
Description
sCD163 levels in plasma
Time Frame
30 days
Title
interleukin-6 (IL-6)
Description
IL-6 levels in plasma
Time Frame
30 days
Title
monocyte chemoattractant protein-1 (MCP-1)
Description
MCP-1 levels in plasma
Time Frame
30 days
Title
tumor necrosis factor alpha (TNF-a)
Description
TNF-a levels in plasma
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mollie Monnig, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics, Immune Function, and the Brain in Alcohol Consumers

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