Probiotics, Immune Function, and the Brain in Alcohol Consumers

NCT05232682 | Completed Phase 2 Results DMC

• 2 other identifiers: 2109003092P01AA019072
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol; Use, Problem

Keywords

alcohol use; probiotics; heavy drinking; brain; immune function

Outcome Measures

Primary Outcomes (6)

• Lipopolysaccharide Binding Protein (LBP)

  LBP levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

• Soluble Cluster of Differentiation 14 (sCD14)

  sCD14 levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

• Soluble Cluster of Differentiation 163 (sCD163)

  sCD163 levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

• Interleukin-6 (IL-6)

  IL-6 levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

• Monocyte Chemoattractant Protein-1 (MCP-1)

  MCP-1 levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

• Tumor Necrosis Factor Alpha (TNF-a)

  TNF-a levels in plasma

  30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.

Study Arms (1)

Probiotic Arm

EXPERIMENTAL

Probiotic arm

Dietary Supplement: Seed DS-01 Daily Synbiotic

Interventions

Seed DS-01 Daily Synbiotic DIETARY_SUPPLEMENT

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

Probiotic Arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Results Point of Contact

• Title: Mollie Monnig, PhD
• Organization: Brown University

mollie_monnig@brown.edu

4018633491

Study Officials

• Mollie Monnig, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, open label trial

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: February 24, 2022
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)