Alcohol Use Disorder
Conditions
Keywords
Probiotics, Alcohol use disorder, Pilot trial, Gut-brain axis
Brief summary
Alcohol Use Disorder (AUD) is a common condition that can affect physical and mental health. Current treatments do not work for everyone, and new approaches are needed. The primary aim of this study is to assess whether taking a specific probiotic supplement (a type of "good bacteria") is a feasible approach for people with AUD - that is, whether it is practical, acceptable, and well-tolerated within this population. As a secondary aim, the study also explores whether the probiotic may help improve psychological, biological, and cognitive wellbeing. Participants are randomly assigned to receive either a probiotic supplement or a placebo (a capsule with no active ingredients) for four weeks. Neither the participants nor the researchers know which treatment is given during the study. The aim is to understand whether probiotics could be a feasible and helpful additional approach to support people with AUD.
Interventions
DIETARY_SUPPLEMENTProbiotic Formula Capsule
A probiotic is randomly administered to patients with alcohol use disorder
DIETARY_SUPPLEMENTPlacebo
A placebo is randomly administered to patients with alcohol use disorder
Sponsors
Loughborough University
Innovate UK
Cultech Ltd, Port Talbot, UK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo and probiotics are randomly assigned at the same time in a triple-blinded study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A self-reported history of heavy drinking * At least one heavy drinking episode (≥8 units) in the last 28 days
Exclusion criteria
* Participants being under 18 years of age * Supplementation of probiotics or prebiotics within the past 4 weeks * Antibiotic use within the past 4 weeks * Major psychiatric conditions diagnosed e.g., bipolar disorder, schizophrenia * Current pregnancy or breastfeeding * Having had a heavy drinking episode (≥8 units) in the last 12 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling | From enrollment to the end of treatment at 4 weeks | Recruitment rate will be calculated as the number of participants enrolled divided by the total number of participants assessed for eligibility, expressed as a percentage. |
| Retention Rate, Defined as the Proportion of Enrolled Participants Completing the 4-Week Intervention | From enrollment to the end of treatment at 4 weeks | Retention rate will be calculated as the number of participants completing the 4-week intervention divided by the total number enrolled, expressed as a percentage, and will be reported overall and by study arm. |
| Intervention Adherence, Assessed by Capsule Count | From enrollment to the end of treatment at 4 weeks | Adherence will be calculated as the number of capsules consumed relative to the 28 capsules prescribed across the 4-week intervention period, based on participant-reported capsule counts, and expressed as a percentage of the total prescribed dose. |
| Participant Acceptability, Assessed by Verbal Feedback | From enrollment to the end of treatment at 4 weeks | Acceptability of the intervention will be assessed via verbal feedback requested from the participants at the end of the 4-week intervention period, covering participants' experience of intervention components including capsule-taking and stool sample collection procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 38 participants with Alcohol Use Disorder assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12 | From enrollment to the end of the treatment at 4 weeks | Mental health symptoms will be assessed using the Depression Anxiety Stress Scales-12 (DASS-12), a 12-item self-report questionnaire measuring symptoms of depression, anxiety, and stress. Each item is rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total DASS-12 score (range 0-36), with higher scores indicating greater psychological distress. |
| 38 participants with Alcohol Use Disorder assessed for Response Inhibition by Go/No-Go task | From enrollment to the end of the treatment at 4 weeks | Response inhibition will be assessed using a computerized Go/No-Go task. Participants are required to respond to "go" stimuli and withhold responses to "no-go" stimuli. Performance will be measured as the number of commission errors (responses during no-go trials; count) and the number of correct responses (correct responses to go trials; count), with higher commission errors indicating poorer response inhibition and higher correct responses indicating better task performance. |
| 38 participants with Alcohol Use Disorder assessed for Alcohol Craving by Penn Alcohol Craving Scale | From enrollment to the end of the treatment at 4 weeks | Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), a 5-item self-report questionnaire measuring frequency, intensity, and duration of alcohol cravings over the past week. Each item is rated on a scale from 0 to 6, yielding a total score ranging from 0 to 30. Performance will be measured as the total PACS score (range 0-30), with higher scores indicating greater alcohol craving severity. |
| 38 participants with Alcohol Use Disorder assessed for Gut Microbiome Composition by 16S rRNA Gene Sequencing | From enrollment to the end of the treatment at 4 weeks | Gut health will be assessed using 16S ribosomal RNA (rRNA) gene sequencing of stool samples collected and analysed in the laboratory. Microbial composition will be characterised using standard bioinformatics pipelines. Outcomes will include alpha diversity (within-sample diversity; e.g., Shannon diversity index) and beta diversity (between-sample differences in microbial composition). Performance will be measured as diversity indices (unitless values) and distance metrics for beta diversity, with higher alpha diversity generally indicating greater microbial diversity and gut health. |
| 38 participants with Alcohol Use Disorder assessed for Working Memory by n-back task | From enrollment to the end of the treatment at 4 weeks | Working memory will be assessed using a computerized N-back task (1-back, 2-back, 3-back conditions). Participants respond when a stimulus matches one presented previously (1-3 trials earlier). The task includes 50 trials per condition with 10 target stimuli. Each stimulus is presented for 1000 ms. Performance will be measured based on the number of commission errors (count) and number of correct responses (count), with higher correct responses indicating better working memory performance and higher commission errors indicating poorer performance. |
| 38 participants with Alcohol Use Disorder assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire | From enrollment to the end of the treatment at 4 weeks | Drinking behaviour will be assessed using the Loughborough Alcohol Drinking Questionnaire (LoAD-Q), a 33-item self-report questionnaire measuring three dimensions: emotional drinking, external drinking, and restrained drinking. Each item is rated on a 5-point Likert scale (1 = never to 5 = very often). Subscale scores are calculated by summing item responses within each dimension. The emotional drinking subscale (13 items) has a score range of 13 to 65, the external drinking subscale (10 items) ranges from 10 to 50, and the restrained drinking subscale (10 items) ranges from 10 to 50. Performance will be measured as subscale total scores, with higher scores indicating greater levels of emotional, external, and restrained drinking behaviour, respectively. |
| 38 participants with Alcohol Use Disorder assessed for Attention by Visual Search task | From enrollment to the end of the treatment at 4 weeks | Attention will be assessed using a computerized visual search task in which participants identify target stimuli among distractors. Performance will be measured as reaction time (milliseconds) and accuracy (percentage of correct responses, %) across trials, with lower reaction times indicating better attentional performance and higher accuracy indicating better task performance. |
| 38 participants with Alcohol Use Disorder assessed for Cognitive Bias by Rough Estimation Task | From enrollment to the end of the treatment at 4 weeks | Cognitive bias will be assessed using the Rough Estimation Task (REsT), where participants read a list of alcohol-related, semantically related, and unrelated words and estimate the proportion of alcohol-related words. Performance will be measured as the percentage (%) of words estimated as alcohol-related, with overestimation (\>33%) indicating cognitive bias. |
Countries
United Kingdom
Outcome results
None listed