Probiotic Study in Alcohol Recovery

Loughborough University

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Dietary Supplement: Probiotic Formula Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT07510113

22834

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 OR a breath alcohol reading above 35 µg/100 ml

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Probiotic Group

Active Comparator group

Description:

Capsules contain the active ingredient (live bacteria)

Treatment:

Dietary Supplement: Probiotic Formula Capsule

Placebo Group

Placebo Comparator group

Description:

Capsules look identical to the probiotic but contain no live bacteria

Treatment:

Dietary Supplement: Probiotic Formula Capsule