Clinical trial NCT05232682: Probiotics, Immune Function, and the Brain in Alcohol Consumers
Official title: Probiotics, Immune Function, and the Brain in Alcohol Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol; Use, Problem
Keywords: alcohol use
probiotics
heavy drinking
brain
immune function
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, open label trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Lipopolysaccharide Binding Protein (LBP)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
measure: Soluble Cluster of Differentiation 14 (sCD14)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
measure: Soluble Cluster of Differentiation 163 (sCD163)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
measure: Interleukin-6 (IL-6)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
measure: Monocyte Chemoattractant Protein-1 (MCP-1)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
measure: Tumor Necrosis Factor Alpha (TNF-a)
timeFrame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Mollie Monnig, PhD
role: PRINCIPAL_INVESTIGATOR
References: