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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
A probiotic is randomly administered to patients with alcohol use disorder
A placebo is randomly administered to patients with alcohol use disorder
Loughborough University
Loughborough, United Kingdom
Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Retention Rate, Defined as the Proportion of Enrolled Participants Completing the 4-Week Intervention
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Intervention Adherence, Assessed by Capsule Count
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Acceptability, Assessed by Verbal Feedback
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.
Time frame: From enrollment to the end of treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Response Inhibition by Go/No-Go task
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Alcohol Craving by Penn Alcohol Craving Scale
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Gut Microbiome Composition by 16S rRNA Gene Sequencing
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Working Memory by n-back task
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Attention by Visual Search task
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
38 participants with Alcohol Use Disorder assessed for Cognitive Bias by Rough Estimation Task
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.
Time frame: From enrollment to the end of the treatment at 4 weeks
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