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COMPLETED

NCT05830708

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

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

Summary

This two-armed, parallel-group, double-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with placebo 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 placebo to mitigate common comorbid of AUD (such as depression and anxiety symptoms); 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, 28 patients diagnosed with AUD (using Diagnostic and Statistical Manual for Mental Disorders 5th Edition or DSM-5) and 18 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, 58 AUD patients will be randomized into two groups of intervention in a 1:1 ratio (Lactobacillus sp. probiotic and placebo group; n = 29 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. 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), and fecal microbiota content.

Official title: The Efficacy of Probiotics for the Treatment of Alcohol Use Disorder Among Adult Males: A Comparison With Placebo and Acceptance and Commitment Therapy in a Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-06-01

Completion Date

2024-06-30

Last Updated

2026-07-02

Healthy Volunteers

Yes

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.

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.

Inclusion Criteria (AUD patients): * Hospitalized patients diagnosed with untreated alcohol use disorder (confirmed by the diagnostic criteria of DSM-5). * Male, age 18 to 55 years old, Han nationality, junior high school education or above, right-handed. * Those with normal eyesight, including corrected vision(screened clinically). Exclusion Criteria (AUD patients): * The patient suffer from other mental illnesses (screen by DSM-V criteria). * The patient has allergy reaction to medications use for conventional treatment of alcohol use disorder. * The patient had a history of organic brain disease, a pacemaker, gastrointestinal surgery, or serious health problems. * The patient had a history of seizures. * The patient is complicated with severe physical disease. * Patient has other drug dependence (except for nicotine dependence). * The patient took drugs affecting intestinal flora 30 days before and during admission. * The patient has participated in any other alcohol-related studies or trials within the past 30 days. * Patients had use any prescription or over-the-counter drugs in the past 30 days that may affect mood or alcohol cravings. Inclusion Criteria (controls): * Male, age 18 to 55 years old, Han nationality, junior high school education or above, right-handed. * No history of psychoactive substance abuse, except tobacco (screen with urine dipstick test). * Those with normal eyesight, including corrected vision (screen clinically). * No alcoholic beverages in the last 2 weeks. * According to the WHO healthy alcohol consumption standard, the average intake of pure alcohol per week is less than 210 grams, or do not drink at all (screen clinically). Exclusion Criteria (controls): * Those who suffer from other mental illnesses (screen by DSM-V criteria). * Those who has history of organic brain disease, a pacemaker, gastrointestinal surgery, or serious health problems. * Those who has history of seizures. * Those complicated with severe physical disease. * Those with drug dependence, including alcohol dependence (exception for nicotine dependence). * Those who took drugs affecting intestinal flora 30 days before and during admission. * Those who has participated in any other alcohol-related studies or trials within the past 30 days. * Those who use any prescription or over-the-counter drugs in the past 30 days that may affect mood or alcohol cravings.

Locations (1)

Second Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China