Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 23

Exploring the effects of binge drinking on gut microbiota and brain function in young adults

Official title: The Brain, the Bug, and the Binge: a Double-blind, Randomized Controlled Trial Investigating the Interplay Between Binge Drinking, Gut Microbiota and Brain Functioning

Run by University of Minho · NCT05946083 · Data updated 2026-11-12

This study is testing how binge drinking affects gut health and brain function in young adults aged 18-23, and whether a special type of probiotic can help improve these issues.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 23 Years
SexAll
Enrollment82 (estimated)
SponsorUniversity of Minho
Academic / other
Locations1 site (Braga, Gualtar, Braga)
StatusRecruiting
StartedFebruary 24, 2023
Main results expectedJuly 31, 2025
Study endsNovember 30, 2025
Registry record updatedJuly 16, 2025
Trial IDNCT05946083 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are college students aged 18-23 who either engage in binge drinking or are non/low-drinkers.

Probably not a fit

Patients with a history of alcohol abuse, illicit drug use, or significant psychological disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between binge drinking, gut microbiota, and brain function in young college students aged 18-23. It aims to understand how alcohol consumption affects gut health and cognitive performance through various assessments, including brain imaging and cognitive tests. Participants will be categorized as binge drinkers or non/low-drinkers based on their drinking patterns and will undergo interventions with psychobiotics to evaluate potential improvements in gut microbiota and brain function. The research will be conducted at the University of Minho in Portugal, utilizing both in-vivo and in-vitro methodologies.

Why it matters

Potential benefit: If successful, this study could lead to new interventions that mitigate the negative effects of binge drinking on brain health in young adults.

How similar studies have gone: While the interplay between binge drinking, gut microbiota, and brain function is a relatively unexplored area, some studies have shown promising results with psychobiotic interventions in related contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* College students whose native language is Portuguese;
* Age 18-23 years;
* Binge Drinkers: report (i) drinking 4 (for women)/5 (for men) or more drinks on one occasion at least once a month, (ii) drinking at a speed of at least two drinks per hour during these episodes (which brings blood alcohol concentration to 0.08 g/dL or above), and (iii) having an AUDIT score \< 20.
* Non/Low-Drinkers: report (i) never drinking 4/5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.

Exclusion Criteria:

* Use of illicit drugs as determined by the Drug Use Disorders Identification Test (DUDIT);
* Alcohol abuse (i.e., AUDIT ≥ 20);
* Personal history of psychopathological disorders (according to DSM-V criteria);
* History of traumatic brain injury or neurological disorder;
* Family history (mother/father) of alcoholism diagnosis of substance abuse;
* Occurrence of one or more episodes of loss of consciousness for more than 30 minutes;
* Non-corrected sensory deficits;
* Diagnosis of any gut disease/problems or other medical conditions: inflammatory bowel disease, irritable bowel syndrome, Crohn's Disease, celiac disease, lactose intolerance, autoimmune disease;
* Consumption of medical drugs with psychoactive effects (e.g., antidepressants, anxiolytics or benzodiazepines) during the 4 weeks prior to the experiment;
* Use of any of the following drugs in the last 4 weeks: laxatives, antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs, analgesics, corticosteroids;
* No type of metal object implanted in the body, especially in the head (orthodontic appliances are not excluded).

Where it's running

  • Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho
    Braga, Gualtar, Braga, Portugal
    Recruiting

Study contacts

  • Principal investigator: Eduardo G. López-Caneda, PhD — Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.
  • Study coordinator: Eduardo G. López-Caneda, PhD
  • Email: eduardo.lopez@psi.uminho.pt
  • Phone: (+351) 253 604 223

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.