Probiotic Study in Alcohol Recovery

NCT07510113 | Completed

• 1 other identifier: 22834
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Probiotics; Alcohol use disorder; Pilot trial; Gut-brain axis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  From enrollment to the end of the treatment at 4 weeks

Other Outcomes (3)

• 38 participants with Alcohol Use Disorder assessed for Inflammation by Salivary Interleukin-6 (IL-6) using Enzyme-Linked Immunosorbent Assay (ELISA)

  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

  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)

  From enrollment to the end of the treatment at 4 weeks

Study Arms (2)

Probiotic Group

ACTIVE COMPARATOR

Capsules contain the active ingredient (live bacteria)

Dietary Supplement: Probiotic Formula Capsule

Placebo Group

PLACEBO COMPARATOR

Capsules look identical to the probiotic but contain no live bacteria

Dietary Supplement: Placebo

Interventions

Probiotic Formula Capsule DIETARY_SUPPLEMENT

A probiotic is randomly administered to patients with alcohol use disorder

Probiotic Group

Placebo DIETARY_SUPPLEMENT

A placebo is randomly administered to patients with alcohol use disorder

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A self-reported history of heavy drinking
• At least one heavy drinking episode (≥8 units) in the last 28 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead
• Innovate UK: collaborator
• Cultech Ltd, Port Talbot, UK: collaborator

Study Sites (1)

Loughborough University

Loughborough, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Model Details: Placebo and probiotics are randomly assigned at the same time in a triple-blinded study design

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 3, 2026
• Study Start: December 15, 2025
• Primary Completion: April 17, 2026
• Study Completion: May 17, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

GB (1)