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

StatusRecruiting
PhasePhase 2
Started
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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.

Record History

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  1. Primary completion date: Jun 30, 2024 to Jul 31, 2025v2 Show 4 more changesShow less
    • Primary endpoints: 33 to 6
    • Study completion date: Aug 31, 2025 to Nov 30, 2025
    • Start date: Feb 17, 2023 to Feb 24, 2023
    • Secondary endpoints expanded, about 140 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05946083
Lead Sponsor University of Minho
Collaborators: Foundation for Science and Technology, Portugal
Conditions
(from sponsor)		 Binge Drinking
Related terms Binge Drinking
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov