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

NCT05946083 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-07-16

No results posted yet for this study

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.

Conditions

  • Binge Drinking

Interventions

DIETARY_SUPPLEMENT

Inulin Intervention

For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of a dietary fiber with benefits for intestinal bacteria (inulin).

DIETARY_SUPPLEMENT

Maltodextrin Intervention

For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of dietary fiber with no specific benefits for the intestinal microbiome (maltodextrin).

Sponsors & Collaborators

  • Foundation for Science and Technology, Portugal

    collaborator OTHER

  • University of Minho

    lead OTHER

Principal Investigators

  • Eduardo G. López-Caneda, PhD · Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-24
Primary Completion
2025-07-31
Completion
2025-11-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946083 on ClinicalTrials.gov