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

Recruiting now · Phase 2

Conditions studied: Binge Drinking

In brief

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.

Key facts

Study ID: NCT05946083
Run by: University of Minho
People needed: 82
Starts: 2023-02-24
Expected to finish: 2025-11-30
Last updated by the study team: 2025-07-16

Who can join

Age: 18 and older, up to 23. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho — Braga, Gualtar, Braga, Portugal (enrolling)

Full record on ClinicalTrials.gov

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