Binge DrinkingPhase 2NCT05946083
The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning
A Phase 2 study testing Inulin Intervention and Maltodextrin Intervention in people with Binge Drinking, run by University of Minho at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking
- What is being tested?
- Inulin Intervention and Maltodextrin Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 sitePortugal
- Study dates
- 24 Feb 2023to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clarisse N. Gonçalves, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho
Braga, Gualtar, Braga, 4710-057
Eduardo G. López-Caneda, PhD, (+351) 253 604 223, eduardo.lopez@psi.uminho.pt
Clarisse N. Gonçalves, PhD, clarissenobre@deb.uminho.pt
About this study
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
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.
Read the detailed description
The present study protocol aims to determine the interaction between alcohol consumption, brain function and gut microbiota through several levels of analysis, including techniques to measure brain activity (i.e., magnetic resonance imaging), paradigms to measure cognitive performance, collection of stool and blood samples, and questionnaires. Additionally, this study will investigate the relationship between alcohol, brain activity and gut microbiota and how this can be modified through our diet. The sample will be composed by a cohort of young college students (18-23 years) from the University of Minho (UM; Braga, Portugal) selected according to their drinking patterns. Eighty-two participants will be recruited from UM: 36 non/low-drinkers and 46 binge drinkers (BDs) matched for age and gender. Recruitment will be carried out through an online survey broadcasted using the institutional email. This survey will include a simple sociodemographic section and items regarding the use of alcohol (Alcohol Use Disorder Identification Test - AUDIT, frequency of alcohol consumption, number of drinks consumed on each day of the past week, speed of drinking, etc.). After sample selection, participants will be submitted to the following steps: (1) clinical interview - addresses questions relating to psychological, medical, personal and family history, including questions related to history of alcohol and drug use and some specific questionnaires relating to substance use, as well as those related to physical and psychological symptoms, and personality; (2) neuroimaging assessment - will consist of a structural and functional magnetic resonance imaging (fMRI) at the Hospital de Guimarães (Portugal), while performing different cognitive tasks; (3) evaluation of some microorganisms residing in the gut and certain inflammatory markers - each participant will be asked to collect stool and blood samples; (4) evaluation of the potential of an intervention with psychobiotics.
Thus, this protocol involves the following phases:
- pre-intervention, consisting of the assessment of the variables of interest to the study by means of a clinical interview, neuropsychological testing, collection of stool and blood samples, and MRI recordings.
- intervention (only for BDs), consisting of taking a prebiotic for 6 weeks. Depending on the group to which they will be allocated, the participant will take one of two types of fiber: a fiber with benefits for intestinal bacteria (inulin) or a similar fiber with no specific benefits for the intestinal microbiome (maltodextrin). Each participant will not know which group they belong to in order not to bias the results of the study according to scientific standards.
- post-intervention, which will consist in the re-assessment of the variables previously assessed in the pre-intervention phase.
- follow-up, consisting of the assessment and monitoring of levels of alcohol consumption and craving during the 3 months following the intervention phase.
- Conditions
- Binge Drinking
- Being tested
- Inulin Intervention, Maltodextrin Intervention
- Keywords
- Adolescence, Young Adulthood, Alcohol, Binge Drinking, Gut Microbiome, Microbiota-Gut-Brain Axis, Magnetic Resonance Imaging, Pro-inflammatory cytokines, Psychobiotics, Randomized Controlled Trial
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin InterventionDietary 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).
Maltodextrin InterventionDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Binge Drinkers with Inulin Intervention | Active comparator | 23 binge drinkers (~50 % male and ~50 % female) will be given a daily dose of inulin. Receives: 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. Receives: Dietary Supplement: Maltodextrin Intervention |
| Non/Low-Drinkers | No intervention | 36 non/low-drinkers will not be given any dietary fiber. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Immediately post-intervention.
Secondary outcomes (24)
Alcohol Consumption - Drinking pattern
The AUDIT will be administered to characterize the drinking pattern of the participants. AUDIT scores ≤ 4 reveal low risk of alcohol use; scores between 5 and 20 represent excessive alcohol consumption; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.
Measured: Immediately post-intervention
Alcohol Consumption - Drinking pattern
The AUDIT will be administered to characterize the drinking pattern of the participants. AUDIT scores ≤ 4 reveal low risk of alcohol use; scores between 5 and 20 represent excessive alcohol consumption; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.
Measured: 3 months post-intervention
Alcohol Craving - Short-term acute craving
Short-term alcohol craving levels will be assessed using the ACQ-SF-R at the present moment. Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving).
Measured: Immediately post-intervention
Alcohol Craving - Short-term acute craving
Short-term alcohol craving levels will be assessed using the ACQ-SF-R at the present moment. Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving).
Measured: 3 months post-intervention
Neuropsychological Evaluation - Memory
The Delayed Matching to Sample (DMS) from Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns.
Measured: At baseline (pre-intervention)
Neuropsychological Evaluation - Memory
The Delayed Matching to Sample (DMS) from Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns.
Measured: Immediately post-intervention
Neuropsychological Evaluation - Emotion and Social Cognition
The Emotion Recognition Task (ERT) from CANTAB will measure the ability to identify six basic emotions (sadness, happiness, fear, anger, disgust, and surprise) in facial expressions along a continuum of expression magnitude.
Measured: At baseline (pre-intervention)
Neuropsychological Evaluation - Emotion and Social Cognition
The Emotion Recognition Task (ERT) from CANTAB will measure the ability to identify six basic emotions (sadness, happiness, fear, anger, disgust, and surprise) in facial expressions along a continuum of expression magnitude.
Measured: Immediately post-intervention
Neuropsychological Evaluation - Executive Function
The performance of the cognitive domain comprising high-level thinking and decision-making will be assessed through CANTAB, namely the Cambridge Gambling Task (CGT, to assess decision-making and risk behaviour outside a learning context), Intra-Extra Dimensional Set Shift (IED, to assess cognitive flexibility), Spatial Working Memory (SWM, to identify working memory strategies and errors) and Stop Signal Task (SST, to measure response inhibition/impulse control).
Measured: At baseline (pre-intervention)
Neuropsychological Evaluation - Executive Function
The performance of the cognitive domain comprising high-level thinking and decision-making will be assessed through CANTAB, namely the Cambridge Gambling Task (CGT, to assess decision-making and risk behaviour outside a learning context), Intra-Extra Dimensional Set Shift (IED, to assess cognitive flexibility), Spatial Working Memory (SWM, to identify working memory strategies and errors) and Stop Signal Task (SST, to measure response inhibition/impulse control).
Measured: Immediately post-intervention
Alcohol Cue Reactivity - Emotional measures
The reactivity to alcoholic cues will be assessed using the Alcohol Cue Reactivity (ACR) task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task.
Measured: At baseline (pre-intervention)
Alcohol Cue Reactivity - Emotional measures
The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task.
Measured: Immediately post-intervention.
Memory Inhibition Performance
Memory Inhibition (MI), specifically alcohol-related MI, will be assessed using the Think/No-Think Alcohol (TNTA) task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase.
Measured: At baseline (pre-intervention)
Memory Inhibition Performance
MI, specifically alcohol-related MI, will be assessed using the TNTA task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase.
Measured: Immediately post-intervention.
Ability of Emotional Recognition
Emotional recognition capacity will be assessed through the Emotion Discrimination (ED) task. ED assesses the brain's preconscious and conscious responses to emotional faces. The complete task includes a total of 120 images of human faces (60 men and 60 women), showing the main negative emotions: angry, sadness and fear.
Measured: At baseline (pre-intervention)
Ability of Emotional Recognition
Emotional recognition capacity will be assessed through the ED task. ED assesses the brain's preconscious and conscious responses to emotional faces. The complete task includes a total of 120 images of human faces (60 men and 60 women), showing the main negative emotions: angry, sadness and fear.
Measured: Immediately post-intervention.
Blood samples - Presence of Inflammatory Markers
Blood samples will be collected from all participants. The presence and abundance of the following cytokines will be analyzed: Tumour Necrosis Factor α (TNF-α) and Interleukins (IL-1β, IL-6, IL-10).
Measured: At baseline (pre-intervention)
Blood samples - Presence of Inflammatory Markers
Blood samples will be collected only from binge drinkers subjected to the intervention. The presence and abundance of the following cytokines will be analyzed: Tumour Necrosis Factor α (TNF-α) and Interleukins (IL-1β, IL-6, IL-10).
Measured: Immediately post-intervention.
Neurofunctional level - Think/No-Think Alcohol (TNTA) Task
The TNTA task assesses memory inhibition mechanisms in alcohol-related contexts. It involves three phases - Learning, Think/No-Think and Memory Test - during which participants memorise pairs of images (human faces with a neutral expression and alcoholic/non-alcoholic beverages) and are subsequently instructed to actively recall or suppress these associations.
Measured: At baseline (pre-intervention)
Neurofunctional level - Think/No-Think Alcohol (TNTA) Task
The TNTA task assesses memory inhibition mechanisms in alcohol-related contexts. It involves three phases - Learning, Think/No-Think and Memory Test - during which participants memorise pairs of images (human faces with a neutral expression and alcoholic/non-alcoholic beverages) and are subsequently instructed to actively recall or suppress these associations.
Measured: Immediately post-intervention
Neurofunctional level - Emotional Face Matching (EFM) Task
The EFM task assesses emotional recognition ability and pre-conscious and conscious neural responses to emotional faces and geometric forms. During each trial, participants view three emotional faces or shapes (one on top and two on the bottom, in a triangular configuration) and are instructed to identify the emotion/shape at the top of the screen and match it with the corresponding one at the bottom using handheld response buttons.
Measured: At baseline (pre-intervention)
Neurofunctional level - Emotional Face Matching (EFM) Task
The EFM task assesses emotional recognition ability and pre-conscious and conscious neural responses to emotional faces and geometric forms. During each trial, participants view three emotional faces or shapes (one on top and two on the bottom, in a triangular configuration) and are instructed to identify the emotion/shape at the top of the screen and match it with the corresponding one at the bottom using handheld response buttons.
Measured: Immediately post-intervention
Neurofunctional level - Alcohol Cue Reactivity (ACR) Task
The ACR task assesses the emotional and attentional response to alcoholic stimuli. Participants are shown images of alcoholic and non-alcoholic drinks, interspersed with oddball blocks containing neutral objects, to which they must respond by pressing a button. After viewing all images, participants are asked to rate their emotional responses to the alcoholic or non-alcoholic beverage images in terms of valence, arousal, and desire.
Measured: At baseline (pre-intervention)
Neurofunctional level - Alcohol Cue Reactivity (ACR) Task
The ACR task assesses the emotional and attentional response to alcoholic stimuli. Participants are shown images of alcoholic and non-alcoholic drinks, interspersed with oddball blocks containing neutral objects, to which they must respond by pressing a button. After viewing all images, participants are asked to rate their emotional responses to the alcoholic or non-alcoholic beverage images in terms of valence, arousal, and desire.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start24 Feb 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Eduardo López-Caneda, University of Minho
- Investigators
- Eduardo G. López-Caneda, PhD, Principal investigator, Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946083
- Sponsor's protocol ID
- CEICSH 078/2022
- Other IDs
- PTDC/PSI-ESP/1243/2021
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36739238Sousa 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.
PubMed 31487578Almeida-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.
PubMed 33418172White 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.
PubMed 24881329Carbia 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.
PubMed 33288871Cryan 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.
PubMed 22968153Cryan 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.
PubMed 31753762Leclercq 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.
PubMed 25288760Leclercq 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.
PubMed 28244981Jadhav 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.
PubMed 30172845Leclercq 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.
PubMed 30031625Lannoy 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.
PubMed 31328014Lopez-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.
PubMed 30375668Prata-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.
PubMed 40908013
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05946083
- Acronym / sponsor ID
- CEICSH 078/2022
- Conditions
- Binge Drinking
- Keywords
- Adolescence, Young Adulthood, Alcohol, Binge Drinking, Gut Microbiome, Microbiota-Gut-Brain Axis, Magnetic Resonance Imaging, Pro-inflammatory cytokines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study protocol aims to determine the interaction between alcohol consumption, brain function and gut microbiota through several levels of analysis, including techniques to measure brain activity (i.e., magnetic resonance imaging), paradigms to measure cognitive performance, collection of stool and blood samples, and questionnaires. Additionally, this study will investigate the relationship between alcohol, brain activity and gut microbiota and how this can be modified through our diet. The sample will be composed by a cohort of young college students (18-23 years) from the University of Minho (UM; Braga, Portugal) selected according to their drinking patterns. Eighty-two participants will be recruited from UM: 36 non/low-drinkers and 46 binge drinkers (BDs) matched for age and gender. Recruitment will be carried out through an online survey broadcasted using the institutional email. This survey will include a simple sociodemographic section and items regarding the use of alcohol (Alcohol Use Disorder Identification Test - AUDIT, frequency of alcohol consumption, number of drinks consumed on each day of the past week, speed of drinking, etc.). After sample selection, participants will be submitted to the following steps: (1) clinical interview - addresses questions relating to psychological, medical, personal and family history, including questions related to history of alcohol and drug use and some specific questionnaires relating to substance use, as well as those related to physical and psychological symptoms, and personality; (2) neuroimaging assessment - will consist of a structural and functional magnetic resonance imaging (fMRI) at the Hospital de Guimarães (Portugal), while performing different cognitive tasks; (3) evaluation of some microorganisms residing in the gut and certain inflammatory markers - each participant will be asked to collect stool and blood samples; (4) evaluation of the potential of an intervention with psychobiotics.
Thus, this protocol involves the following phases:
- pre-intervention, consisting of the assessment of the variables of interest to the study by means of a clinical interview, neuropsychological testing, collection of stool and blood samples, and MRI recordings.
- intervention (only for BDs), consisting of taking a prebiotic for 6 weeks. Depending on the group to which they will be allocated, the participant will take one of two types of fiber: a fiber with benefits for intestinal bacteria (inulin) or a similar fiber with no specific benefits for the intestinal microbiome (maltodextrin). Each participant will not know which group they belong to in order not to bias the results of the study according to scientific standards.
- post-intervention, which will consist in the re-assessment of the variables previously assessed in the pre-intervention phase.
- follow-up, consisting of the assessment and monitoring of levels of alcohol consumption and craving during the 3 months following the intervention phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Binge Drinkers with Inulin Intervention | Active comparator | Dietary Supplement: Inulin Intervention23 binge drinkers (~50 % male and ~50 % female) will be given a daily dose of inulin. |
| Binge Drinkers with Maltodextrin Intervention | Placebo comparator | Dietary Supplement: Maltodextrin Intervention23 binge drinkers (~50 % male and ~50 % female) will be given a daily dose of maltodextrin. |
| Non/Low-Drinkers | No intervention | –36 non/low-drinkers will not be given any dietary fiber. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin InterventionFor 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). | Dietary supplement | Binge Drinkers with Inulin Intervention |
| Maltodextrin InterventionFor 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). | Dietary supplement | Binge Drinkers with Maltodextrin Intervention |
Primary outcome
Fecal Microbiota - Species Richness
Time frame: At baseline (pre-intervention)
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.
Fecal Microbiota - Species Richness
Time frame: Immediately post-intervention.
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.
Fecal Microbiota - Species Diversity
Time frame: At baseline (pre-intervention)
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.
Fecal Microbiota - Species Diversity
Time frame: Immediately post-intervention
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.
Fecal Microbiota - Quantification of SCFAs levels
Time frame: At baseline (pre-intervention)
The concentration of short-chain fatty acids (SCFAs) present in each collected faecal sample shall be quantified by High Performance Liquid Chromatography (HPLC).
Fecal Microbiota - Quantification of SCFAs levels
Time frame: Immediately post-intervention.
The concentration of SCFAs present in each collected faecal sample shall be quantified by HPLC.
24 secondary outcomes
Alcohol Consumption - Drinking pattern
Time frame: Immediately post-intervention
Alcohol Consumption - Drinking pattern
Time frame: 3 months post-intervention
Alcohol Craving - Short-term acute craving
Time frame: Immediately post-intervention
Alcohol Craving - Short-term acute craving
Time frame: 3 months post-intervention
Neuropsychological Evaluation - Memory
Time frame: At baseline (pre-intervention)
Neuropsychological Evaluation - Memory
Time frame: Immediately post-intervention
Neuropsychological Evaluation - Emotion and Social Cognition
Time frame: At baseline (pre-intervention)
Neuropsychological Evaluation - Emotion and Social Cognition
Time frame: Immediately post-intervention
Neuropsychological Evaluation - Executive Function
Time frame: At baseline (pre-intervention)
Neuropsychological Evaluation - Executive Function
Time frame: Immediately post-intervention
Alcohol Cue Reactivity - Emotional measures
Time frame: At baseline (pre-intervention)
Alcohol Cue Reactivity - Emotional measures
Time frame: Immediately post-intervention.
Memory Inhibition Performance
Time frame: At baseline (pre-intervention)
Memory Inhibition Performance
Time frame: Immediately post-intervention.
Ability of Emotional Recognition
Time frame: At baseline (pre-intervention)
Ability of Emotional Recognition
Time frame: Immediately post-intervention.
Blood samples - Presence of Inflammatory Markers
Time frame: At baseline (pre-intervention)
Blood samples - Presence of Inflammatory Markers
Time frame: Immediately post-intervention.
Neurofunctional level - Think/No-Think Alcohol (TNTA) Task
Time frame: At baseline (pre-intervention)
Neurofunctional level - Think/No-Think Alcohol (TNTA) Task
Time frame: Immediately post-intervention
Neurofunctional level - Emotional Face Matching (EFM) Task
Time frame: At baseline (pre-intervention)
Neurofunctional level - Emotional Face Matching (EFM) Task
Time frame: Immediately post-intervention
Neurofunctional level - Alcohol Cue Reactivity (ACR) Task
Time frame: At baseline (pre-intervention)
Neurofunctional level - Alcohol Cue Reactivity (ACR) Task
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 36739238Carbia 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.
- Background: PubMed 31487578Sousa 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.
- Background: PubMed 33418172Almeida-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.
- Background: PubMed 24881329White 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.
- Background: PubMed 33288871Carbia 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.
- Background: PubMed 22968153Cryan 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.
- Background: PubMed 31753762Cryan 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.
- Background: PubMed 25288760Leclercq 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.
- Background: PubMed 28244981Leclercq 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.
- Background: PubMed 30172845Jadhav 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.
- Background: PubMed 30031625Leclercq 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.
- Background: PubMed 31328014Lannoy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clarisse N. Gonçalves, PhD contact
Eduardo G. López-Caneda, PhD principal investigator
Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inulin Intervention and Maltodextrin Intervention in people with Binge Drinking, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo G. López-Caneda, PhD ((+351) 253 604 223, eduardo.lopez@psi.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Microbiota - Species Richness (time frame: At baseline (pre-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05946083, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.