Alcohol Use DisorderNCT07510113
Probiotic Study in Alcohol Recovery
A study testing Probiotic Formula Capsule in people with Alcohol Use Disorder, run by Loughborough University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Probiotic Formula Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2025to 17 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A self-reported history of heavy drinking
- At least one heavy drinking episode (≥8 units) in the last 28 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotic Supplementation in Alcohol Use Disorder: A Randomised, Placebo-Controlled Pilot Trial
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.
Read more
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Probiotic Formula Capsule, Placebo
- Keywords
- Probiotics, Alcohol use disorder, Pilot trial, Gut-brain axis
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula CapsuleDietary supplement
A probiotic is randomly administered to patients with alcohol use disorder
PlaceboDietary supplement
A placebo is randomly administered to patients with alcohol use disorder
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Active comparator | Capsules contain the active ingredient (live bacteria) Receives: Dietary Supplement: Probiotic Formula Capsule |
| Placebo Group | Placebo comparator | Capsules look identical to the probiotic but contain no live bacteria Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Dec 2025
- Primary completion17 Apr 2026
- Study completion17 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo and probiotics are randomly assigned at the same time in a triple-blinded study design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovate UK, Cultech Ltd
- Responsible party
- Principal investigator, Kim-Marie Gehrke, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510113
- Sponsor's protocol ID
- 22834
- Status last verified
- Sep 2026
- First submitted
- 19 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Supplementation in Alcohol Use Disorder: A Randomised, Placebo-Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07510113
- Acronym / sponsor ID
- 22834
- Conditions
- Alcohol Use Disorder
- Keywords
- Probiotics, Alcohol use disorder, Pilot trial, Gut-brain axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Innovate UK, Cultech Ltd
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 3 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo and probiotics are randomly assigned at the same time in a triple-blinded study design
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Active comparator | Dietary Supplement: Probiotic Formula CapsuleCapsules contain the active ingredient (live bacteria) |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboCapsules look identical to the probiotic but contain no live bacteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A self-reported history of heavy drinking
- At least one heavy drinking episode (≥8 units) in the last 28 days
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Probiotic Formula CapsuleA probiotic is randomly administered to patients with alcohol use disorder | Dietary supplement | Probiotic Group |
| PlaceboA placebo is randomly administered to patients with alcohol use disorder | Dietary supplement | Placebo Group |
Primary outcome
Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
38 participants with Alcohol Use Disorder assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12
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
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
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
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
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
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
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
Time frame: From enrollment to the end of the treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Formula Capsule in people with Alcohol Use Disorder, run by Loughborough University at 1 site in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 15 Sep 2026. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.