Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946083
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-06-15
Brief Title:
The Brain the Bug and the Binge the Interplay Between Binge Drinking Gut Microbiota and Brain Functioning
Sponsor:
University of Minho
Organization:
University of Minho
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 compositionfunction may lead to reductions of alcohol-induced brain damage in BD-population a barely unexplored research field with major clinical applications
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 compositionfunction 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 ie 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 nonlow-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
1 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
2 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
3 post-intervention which will consist in the re-assessment of the variables previously assessed in the pre-intervention phase
4 follow-up consisting of the assessment and monitoring of levels of alcohol consumption and craving during the 3 months following the intervention phase
Thus this protocol involves the following phases
1 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
2 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
3 post-intervention which will consist in the re-assessment of the variables previously assessed in the pre-intervention phase
4 follow-up consisting of the assessment and monitoring of levels of alcohol consumption and craving during the 3 months following the intervention phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PTDCPSI-ESP12432021 | OTHER_GRANT | Portuguese Foundation for Science and Technology | None |