BLa80 Improve Drinkers' Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-07-14

Brief Summary

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The goal of this clinical trial is to understand the effects of the probiotic BLa80 on the gut health of people who drink alcohol regularly. We want to find out if this probiotic can help improve the health of the digestive system in those who consume alcohol. The main questions we aim to answer are: Does BLa80 positively change the composition of gut bacteria in alcohol consumers? Participants in this study will: Be randomly assigned to one of two groups. One group will receive the probiotic BLa80, and the other group will receive a placebo (a substance with no active therapeutic effect). Take their assigned treatment for a specified period, as directed by the study protocol. Undergo regular health checks and provide feceal samples for analysis to see how their gut bacteria might have changed during the study. This study is important because it explores whether a specific type of probiotic can help protect or improve gut health in people who drink alcohol, potentially offering a new way to support digestive health.

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Detailed Description

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Conditions

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Alcohol Drinking, Adult Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo group

Group Type PLACEBO_COMPARATOR

BLa80

Intervention Type DIETARY_SUPPLEMENT

Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BLa80.

Probiotic group

Group Type EXPERIMENTAL

BLa80

Intervention Type DIETARY_SUPPLEMENT

Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BLa80.

Interventions

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BLa80

Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BLa80.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Aged 19-45 years, currently consuming alcohol (defined as having consumed alcohol on at least one day in the past 30 days); Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up; No symptoms of alcohol allergy, with a history of alcohol consumption; Have not suffered from gastrointestinal diseases in the past month; Have not taken antibiotics in the past month.

Exclusion Criteria

Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women; Those who experience discomfort such as diarrhea or bloating after taking the test substance; Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions; Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data; Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results; Individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet); Individuals with low body fat, BMI \< 23.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes