Actively Recruiting

Phase 2
Age: 18Years - 23Years
All Genders
Healthy Volunteers
NCT05946083

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

Led by University of Minho · Updated on 2025-07-16

82

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

U

University of Minho

Lead Sponsor

F

Foundation for Science and Technology, Portugal

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 23Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • College students whose native language is Portuguese
  • Aged 18 to 23 years
  • Binge drinkers who report drinking 4 (women)/5 (men) or more drinks on one occasion at least once a month
  • Binge drinkers who drink at a speed of at least two drinks per hour during these episodes
  • Binge drinkers with an AUDIT score below 20
  • Non/low-drinkers who never drink 4/5 or more drinks on one occasion
  • Non/low-drinkers with an AUDIT score of 4 or less
Not Eligible

You will not qualify if you...

  • Use of illicit drugs as determined by the Drug Use Disorders Identification Test
  • Alcohol abuse defined as AUDIT score 20 or higher
  • Personal history of psychopathological disorders (DSM-V criteria)
  • History of traumatic brain injury or neurological disorder
  • Family history of alcoholism or substance abuse
  • Any episode of loss of consciousness lasting more than 30 minutes
  • Uncorrected sensory deficits
  • Diagnosis of gut diseases or other medical conditions including inflammatory bowel disease, irritable bowel syndrome, Crohn's Disease, celiac disease, lactose intolerance, or autoimmune disease
  • Use of psychoactive medical drugs (e.g., antidepressants, anxiolytics, benzodiazepines) in the 4 weeks prior
  • Use of laxatives, antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs, analgesics, or corticosteroids in the last 4 weeks
  • Presence of metal implants in the body, especially in the head (orthodontic appliances allowed)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho

Braga, Gualtar, Braga, Portugal, 4710-057

Actively Recruiting

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Research Team

E

Eduardo G. López-Caneda, PhD

CONTACT

C

Clarisse N. Gonçalves, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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