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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
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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.
This study is investigating whether taking a probiotic supplement (a type of "good bacteria") can help reduce alcohol craving and 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 study measures alcohol craving, gastrointestinal composition, thinking and memory, mental health, and eating and drinking behaviour at the start and end of the study.
The aim is to understand whether probiotics could be a helpful additional approach to support people with AUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Active Comparator | Capsules contain the active ingredient (live bacteria) |
|
| Placebo Group | Placebo Comparator | Capsules look identical to the probiotic but contain no live bacteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula Capsule | Dietary Supplement | A probiotic or placebo is randomly administered to patients with alcohol use disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 38 participants with Alcohol Use Disorder assessed for Inflammation by Salivary Interleukin-6 (IL-6) using Enzyme-Linked Immunosorbent Assay (ELISA) | Inflammation will be assessed using salivary interleukin-6 (IL-6) measured via enzyme-linked immunosorbent assay (ELISA) using commercially available kits according to manufacturer protocols. Performance will be measured as IL-6 concentration in picograms per millilitre (pg/mL), with higher values indicating greater systemic inflammation. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Loughborough | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2026 | Mar 27, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2026 | Mar 27, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Placebo and probiotics are randomly assigned at the same time in a triple-blinded study design
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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. |
| From enrollment to the end of the treatment at 4 weeks |
| 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. | 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. | 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. | From enrollment to the end of the treatment at 4 weeks |
| From enrollment to the end of the treatment at 4 weeks |
| 38 participants with Alcohol Use Disorder assessed for Disordered Eating by Eating Disorder Examination Questionnaire Short Form | Disordered eating behaviours will be assessed using the Eating Disorder Examination Questionnaire Short Form (EDE-QS), a 12-item self-report questionnaire measuring eating disorder psychopathology over the past 7 days. Each item is rated on a 4-point scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total EDE-QS score (range 0-36), with higher scores indicating greater severity of disordered eating behaviours. | From enrollment to the end of the treatment at 4 weeks |
| 38 participants with Alcohol Use Disorder assessed for Physiological Stress by Salivary Cortisol using Enzyme-Linked Immunosorbent Assay (ELISA) | Physiological stress will be assessed using salivary cortisol measured via enzyme-linked immunosorbent assay (ELISA) using commercially available kits according to manufacturer protocols. Performance will be measured as cortisol concentration in nanomoles per litre (nmol/L), with higher values indicating greater physiological stress. | From enrollment to the end of the treatment at 4 weeks |
| 38 participants with Alcohol Use Disorder assessed for Gut Barrier Function by Caco-2 Cell Trans-Epithelial Electrical Resistance (TEER) and Scratch Assay Using Faecal Water Samples | Gut barrier function will be assessed using in vitro assays applying cell-free faecal water prepared from participant stool samples to a Caco-2 intestinal epithelial cell model. Barrier integrity will be evaluated using trans-epithelial electrical resistance (TEER) measurements, and epithelial repair will be assessed using a scratch (wound healing) assay. Performance will be measured as TEER values (ohms·cm²) and percentage wound closure (%), with higher TEER values indicating improved barrier integrity and greater wound closure indicating enhanced epithelial repair capacity. | From enrollment to the end of the treatment at 4 weeks |