Exploring the effects of binge drinking on gut microbiota and brain function in young adults
The Brain, the Bug, and the Binge: a Double-blind, Randomized Controlled Trial Investigating the Interplay Between Binge Drinking, Gut Microbiota and Brain Functioning
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 23 Years |
| Sex | All |
| Sponsor | University of Minho Academic / other |
| Locations | 1 site (Braga, Gualtar, Braga) |
| Trial ID | NCT05946083 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are college students aged 18-23 who either engage in binge drinking or are non/low-drinkers.
Not a fit: Patients with a history of alcohol abuse, illicit drug use, or significant psychological disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Braga, Gualtar, Braga
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.