Phase 2
N=16
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Alcohol; Use, Problem
Bottom Line
View on ClinicalTrials.gov: NCT05232682 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Lipopolysaccharide Binding Protein (LBP) — 23609.2; 28111.9 ng/ml — p=0.1183
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Seed DS-01 Daily Synbiotic (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lipopolysaccharide Binding Protein (LBP) |
23609.2; 28111.9 | 0.1183 |
| PRIMARY Soluble Cluster of Differentiation 14 (sCD14) |
3175.9; 3394.7 | 0.9308 |
| PRIMARY Soluble Cluster of Differentiation 163 (sCD163) |
518.6; 560.9 | 0.1517 |
| PRIMARY Interleukin-6 (IL-6) |
1.2; 1.2 | 0.8747 |
| PRIMARY Monocyte Chemoattractant Protein-1 (MCP-1) |
93.5; 101.0 | 0.3269 |
| PRIMARY Tumor Necrosis Factor Alpha (TNF-a) |
7.4; 7.6 | 0.3411 |
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).
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.
Data sourced from ClinicalTrials.gov (NCT05232682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.