The Efficacy of Probiotics for the Treatment of Alcohol Use Disorder Among Adult Males

Summary

This three-armed, parallel-group, single-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with that of acceptance and commitment therapy (ACT) in ameliorating alcohol craving and severity of alcohol use disorder (AUD) in patients diagnosed with AUD after 2 weeks of in-patient detoxification. In addition, this study also compares the efficacy of probiotic supplement and ACT to mitigate common comorbid of AUD (such as depression and anxiety symptoms); changes in event-related potential (ERP) on electroencephalogram (EEG) monitoring which indicate reduce alcohol craving; and depreciate the serum level of pro-inflammatory cytokines, such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) indicating lowering of systemic inflammation.

In phase I of the study, 120 patients diagnosed with AUD (using Diagnostic and Statistical Manual for Mental Disorders 5th Edition or DSM-5) and 120 healthy controls will be recruited. The measured outcomes to be compared between patients with AUD and healthy non-AUD controls include ERP on EEG monitoring, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), and the fecal microbiota content. Then, in phase II of the study, 120 AUD patients will be randomized into three groups of intervention in a 1:1:1 ratio (Lactobacillus sp. probiotic, ACT and placebo group; n = 40 per group). The participants in probiotic and placebo groups will then consumed the Lactobacillus sp. Probiotic and placebo 1 sachet once a day of probiotic and placebo, respectively for 12 weeks. While participants in ACT group will undergo training for ACT one session per week for 8 weeks. Outcome assessments will be performed across four time points, such as t0 = before intervention began, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began. The primary outcomes to be measured are the degree of alcohol craving, alcohol withdrawal, and severity of alcohol use disorder. While the secondary outcomes to be assessed are severity of comorbid depression and anxiety symptoms, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), changes in ERP on EEG monitoring, and fecal microbiota content.

Conditions

• Alcohol Use Disorder

Interventions

DIETARY_SUPPLEMENT

Lactobacillus sp. probiotic

The probiotic product contains good bacteria Lactobacillus sp. and primarily maltodextrin as carrier. Sachets of products containing the probiotic appear as light-yellow powder. The probiotic products are kept at storage temperature range below 30oC according to the condition recommended by the manufacturer.

BEHAVIORAL

Acceptance and commitment therapy

The ACT session is initiated by building good therapeutic rapport with the subject and gather important information such as experiential avoidance, external barriers, fusion past, unworkable actions, and strength of the subject, followed by formulation of the case. The session may began with coaching subjects on acknowledging and accepting their unpleasant thoughts and feelings. The therapy will also focus on defusion to reduce behavioral avoidance of unpleasant thoughts and feelings by acknowledging them but focus on the values identified. Mindfulness is also practice to allow focus onto the present and surrounding to create awareness among the subjects that they are many things in the surrounding which is more enjoyable that we can enjoy rather than making effort to distract or change or avoid the unpleasant thoughts and feelings.

DIETARY_SUPPLEMENT

Placebo

The placebo are in powder form prepare in sachet which is light-yellow in color and should be stored in temperature at below 30oC, which is similar to the appearance of the probiotic. Nevertheless, it contains only maltodextrin in same amount as in the placebo.

Sponsors & Collaborators

• Xinxiang medical university

  collaborator OTHER

• Universiti Sains Malaysia

  lead OTHER

Principal Investigators

• Mohammad Farris Iman Leong Bin Abdullah, Dr Psych · Advanced Medical and Dental Institute, Universiti Sains Malaysia (USM)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2026-04-30

Completion

2026-04-30