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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
32
Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
Brown University
Providence, Rhode Island, United States
Lipopolysaccharide Binding Protein (LBP)
LBP levels in plasma
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days: Probiotic Arm is baseline; Probiotic Arm at Follow-up is the 30-day follow-up data on the same group.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.