A Randomized, Double-blind Controlled Trial to Assess the Impact of BLa80 on the Intestinal Health of Individuals Who Consume Alcohol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Drinking, Adult Disease
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 120
- Primary Endpoint
- Changes in gut microbiota
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in gut microbiota
Time Frame: 8 weeks
Collect patient fecal samples, test for 16S rRNA