Probiotics Improve Drinkers' Gut Microbiota

Alcohol Drinking Clinical Trial

Official title:

A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals Who Consume Alcohol.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196892
• Other study ID #: WK2023007
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: Fei Xu, Dr.
• Phone: + 86 13671979116
• Email: xu.fei[@]haut.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to understand the effects of the probiotic Bifidobacterium breve BBr60 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 Bifidobacterium breve BBr60 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 Bifidobacterium breve BBr60, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 15, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Aged 19-45 years, currently consuming alcohol (defined as having consumed alcohol on at least one day in the past 30 days);

2. Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;

3. No symptoms of alcohol allergy, with a history of alcohol consumption;

4. Have not suffered from gastrointestinal diseases in the past month;

5. Have not taken antibiotics in the past month.

Exclusion Criteria:

1. 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;

2. Those who experience discomfort such as diarrhea or bloating after taking the test substance;

3. 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;

4. Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;

5. Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;

6. 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);

7. Individuals with low body fat, BMI < 23.

Related Conditions & MeSH terms

• Adult Disease
• Alcohol Drinking

Intervention

Dietary Supplement:
• Probiotic BBr60
Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BBr60.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in intestinal flora	Collect patient fecal samples, test for 16S rRNA	8 weeks