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

NCT05946083 | Recruiting Phase 2

• 2 other identifiers: CEICSH 078/2022PTDC/PSI-ESP/1243/2021
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adolescence; Young Adulthood; Alcohol; Binge Drinking; Gut Microbiome; Microbiota-Gut-Brain Axis; Magnetic Resonance Imaging; Pro-inflammatory cytokines; Psychobiotics; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (6)

• Fecal Microbiota - Species Richness

  Faecal samples will be collected from all participants for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Chao1 Index will be used as an estimator of nonparametric microbial species richness in each sample.

  At baseline (pre-intervention)

• Fecal Microbiota - Species Richness

  Faecal samples will be collected only from binge drinkers subjected to the intervention for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Chao1 Index will be used as an estimator of nonparametric microbial species richness in each sample.

  Immediately post-intervention.

• Fecal Microbiota - Species Diversity

  Faecal samples will be collected from all participants for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Shannon Diversity Index (metric combining richness and evenness, with equal weighting given to abundant and rare species) and the Simpson Diversity Index (metric of richness and evenness, in which more weighting is given to abundant species) will be used.

  At baseline (pre-intervention)

• Fecal Microbiota - Species Diversity

  Faecal samples will be collected only from binge drinkers subjected to the intervention for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Shannon Diversity Index (metric combining richness and evenness, with equal weighting given to abundant and rare species) and the Simpson Diversity Index (metric of richness and evenness, in which more weighting is given to abundant species) will be used.

  Immediately post-intervention

• Fecal Microbiota - Quantification of SCFAs levels

  The concentration of short-chain fatty acids (SCFAs) present in each collected faecal sample shall be quantified by High Performance Liquid Chromatography (HPLC).

  At baseline (pre-intervention)

• Fecal Microbiota - Quantification of SCFAs levels

  The concentration of SCFAs present in each collected faecal sample shall be quantified by HPLC.

  Immediately post-intervention.

Secondary Outcomes (24)

• Alcohol Consumption - Drinking pattern

  Immediately post-intervention

• Alcohol Consumption - Drinking pattern

  3 months post-intervention

• Alcohol Craving - Short-term acute craving

  Immediately post-intervention

• Alcohol Craving - Short-term acute craving

  3 months post-intervention

• Neuropsychological Evaluation - Memory

  At baseline (pre-intervention)

Study Arms (3)

Binge Drinkers with Inulin Intervention

ACTIVE COMPARATOR

23 binge drinkers (\~50 % male and \~50 % female) will be given a daily dose of inulin.

Dietary Supplement: Inulin Intervention

Binge Drinkers with Maltodextrin Intervention

PLACEBO COMPARATOR

23 binge drinkers (\~50 % male and \~50 % female) will be given a daily dose of maltodextrin.

Dietary Supplement: Maltodextrin Intervention

Non/Low-Drinkers

NO INTERVENTION

36 non/low-drinkers will not be given any dietary fiber.

Interventions

Inulin Intervention DIETARY_SUPPLEMENT

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).

Binge Drinkers with Inulin Intervention

Maltodextrin Intervention DIETARY_SUPPLEMENT

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).

Binge Drinkers with Maltodextrin Intervention

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• University of Minho: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho

Braga, Gualtar, Braga, 4710-057, Portugal

RECRUITING

Related Publications (14)

• Carbia C, Bastiaanssen TFS, Iannone LF, Garcia-Cabrerizo R, Boscaini S, Berding K, Strain CR, Clarke G, Stanton C, Dinan TG, Cryan JF. The Microbiome-Gut-Brain axis regulates social cognition & craving in young binge drinkers. EBioMedicine. 2023 Mar;89:104442. doi: 10.1016/j.ebiom.2023.104442. Epub 2023 Feb 2.

  PMID: 36739238 BACKGROUND

• Sousa SS, Sampaio A, Marques P, Lopez-Caneda E, Goncalves OF, Crego A. Functional and structural connectivity of the executive control network in college binge drinkers. Addict Behav. 2019 Dec;99:106009. doi: 10.1016/j.addbeh.2019.05.033. Epub 2019 Jun 3.

  PMID: 31487578 BACKGROUND

• Almeida-Antunes N, Crego A, Carbia C, Sousa SS, Rodrigues R, Sampaio A, Lopez-Caneda E. Electroencephalographic signatures of the binge drinking pattern during adolescence and young adulthood: A PRISMA-driven systematic review. Neuroimage Clin. 2021;29:102537. doi: 10.1016/j.nicl.2020.102537. Epub 2020 Dec 17.

  PMID: 33418172 BACKGROUND

• White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18. doi: 10.35946/arcr.v35.2.11.

  PMID: 24881329 BACKGROUND

• Carbia C, Lannoy S, Maurage P, Lopez-Caneda E, O'Riordan KJ, Dinan TG, Cryan JF. A biological framework for emotional dysregulation in alcohol misuse: from gut to brain. Mol Psychiatry. 2021 Apr;26(4):1098-1118. doi: 10.1038/s41380-020-00970-6. Epub 2020 Dec 7.

  PMID: 33288871 BACKGROUND

• Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.

  PMID: 22968153 BACKGROUND

• Cryan JF, O'Riordan KJ, Sandhu K, Peterson V, Dinan TG. The gut microbiome in neurological disorders. Lancet Neurol. 2020 Feb;19(2):179-194. doi: 10.1016/S1474-4422(19)30356-4. Epub 2019 Nov 18.

  PMID: 31753762 BACKGROUND

• Leclercq S, Matamoros S, Cani PD, Neyrinck AM, Jamar F, Starkel P, Windey K, Tremaroli V, Backhed F, Verbeke K, de Timary P, Delzenne NM. Intestinal permeability, gut-bacterial dysbiosis, and behavioral markers of alcohol-dependence severity. Proc Natl Acad Sci U S A. 2014 Oct 21;111(42):E4485-93. doi: 10.1073/pnas.1415174111. Epub 2014 Oct 6.

  PMID: 25288760 BACKGROUND

• Leclercq S, de Timary P, Delzenne NM, Starkel P. The link between inflammation, bugs, the intestine and the brain in alcohol dependence. Transl Psychiatry. 2017 Feb 28;7(2):e1048. doi: 10.1038/tp.2017.15.

  PMID: 28244981 BACKGROUND

• Jadhav KS, Peterson VL, Halfon O, Ahern G, Fouhy F, Stanton C, Dinan TG, Cryan JF, Boutrel B. Gut microbiome correlates with altered striatal dopamine receptor expression in a model of compulsive alcohol seeking. Neuropharmacology. 2018 Oct;141:249-259. doi: 10.1016/j.neuropharm.2018.08.026. Epub 2018 Aug 31.

  PMID: 30172845 BACKGROUND

• Leclercq S, Starkel P, Delzenne NM, de Timary P. The gut microbiota: A new target in the management of alcohol dependence? Alcohol. 2019 Feb;74:105-111. doi: 10.1016/j.alcohol.2018.03.005. Epub 2018 Mar 20.

  PMID: 30031625 BACKGROUND

• Lannoy S, Billieux J, Dormal V, Maurage P. Behavioral and Cerebral Impairments Associated with Binge Drinking in Youth: A Critical Review. Psychol Belg. 2019 Mar 29;59(1):116-155. doi: 10.5334/pb.476.

  PMID: 31328014 BACKGROUND

• Lopez-Caneda E, Crego A, Campos AD, Gonzalez-Villar A, Sampaio A. The Think/No-Think Alcohol Task: A New Paradigm for Assessing Memory Suppression in Alcohol-Related Contexts. Alcohol Clin Exp Res. 2019 Jan;43(1):36-47. doi: 10.1111/acer.13916. Epub 2018 Nov 25.

  PMID: 30375668 BACKGROUND

• Prata-Martins D, Nobre C, Almeida-Antunes N, Azevedo P, Sousa SS, Crego A, Cryan J, Sampaio A, Carbia C, Lopez-Caneda E. Assessing the impact of binge drinking and a prebiotic intervention on the gut-brain axis in young adults: protocol for a randomised controlled trial. BMJ Open. 2025 Sep 4;15(9):e095932. doi: 10.1136/bmjopen-2024-095932.

  PMID: 40908013 DERIVED

MeSH Terms

Conditions

Binge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Study Officials

• Eduardo G. López-Caneda, PhD

  Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo G. López-Caneda, PhD

CONTACT

(+351) 253 604 223; eduardo.lopez@psi.uminho.pt

Clarisse N. Gonçalves, PhD

CONTACT

clarissenobre@deb.uminho.pt

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Reseacher

Model Details: Binge Drinkers will be randomly distributed for one of two groups: 23 subjects with inulin intervention and 23 subjects with maltodextrin intervention (\~50 % male and \~50 % female in each group). There will also be a non-interventional control group consisting of 36 non/low-drinkers.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 14, 2023
• Study Start: February 24, 2023
• Primary Completion: July 31, 2025
• Study Completion: November 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)