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

Plain-language summary

This study examined the effect of a Lactobacillus probiotic, compared with placebo, in adult men with alcohol use disorder. Men aged 18-55 diagnosed according to DSM-5 criteria took part. It was a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Universiti Sains Malaysia

Intervention

Lactobacillus sp. probiotic, Placebo

Start date

6/1/2022

Estimated completion

6/30/2024

Countries

China

Related genes

Locations

• Xinxiang, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.