Clinical Trial

The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning

Recruiting Phase 2
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Record status
This record was last updated July 16, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Adolescence and youth are periods of significant maturational changes which seems to involve greater susceptibility to disruptive events in the brain such as binge drinking (BD). This prevalent pattern of consumption -characterized by repeated alcohol intoxications- is of special concern, as it has been associated with major neurocognitive impairments in the young brain. Recent studies indicate that alcohol may disrupt the gut microbiota (GM) and that these disruptions may lead to impairments in brain and behavior. Also, interventions with psychobiotics have been shown to result in reductions in alcohol-induced damage and in improvements on cognitive and brain functioning. Thus, the present proposal will explore the effects of BD on GM. Additionally, a GM intervention with psychobiotics both in-vivo and in-vitro, will determine whether improvements in GM composition/function may lead to reductions of alcohol-induced brain damage in BD-population, a barely unexplored research field with major clinical applications.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-07-06.
Trial Details
NCT Number NCT05946083
Lead Sponsor University of Minho
Collaborators: Foundation for Science and Technology, Portugal
Conditions Binge Drinking
Enrollment 82 participants
Start Date 2023-02-24
Primary Completion 2025-07-31 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-16