Alcohol Drinking, Adult DiseaseNCT06216587
BLa80 Improve Drinkers' Gut Microbiota
A study testing BLa80 in people with Alcohol Drinking, Adult Disease, run by Wecare Probiotics Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Adult Disease
- What is being tested?
- BLa80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind Controlled Trial to Assess the Impact of BLa80 on the Intestinal Health of Individuals Who Consume Alcohol
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.
- Conditions
- Alcohol Drinking, Adult Disease
- Being tested
- BLa80
- Medical subject headings
- Alcohol Drinking, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLa80Dietary supplement
Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BLa80.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: BLa80 |
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: BLa80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota
Collect patient fecal samples, test for 16S rRNA
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Mar 2024 (estimated)
- Primary completion25 Jun 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Drinking, Adult DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216587
- Sponsor's protocol ID
- WK2023008
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Controlled Trial to Assess the Impact of BLa80 on the Intestinal Health of Individuals Who Consume Alcohol
- ClinicalTrials.gov ID
- NCT06216587
- Acronym / sponsor ID
- WK2023008
- Conditions
- Alcohol Drinking, Adult Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: BLa80 |
| Probiotic group | Experimental | Dietary Supplement: BLa80 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLa80Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BLa80. | Dietary supplement | Placebo group, Probiotic group |
Primary outcome
Changes in gut microbiota
Time frame: 8 weeks
Collect patient fecal samples, test for 16S rRNA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing BLa80 in people with Alcohol Drinking, Adult Disease, run by Wecare Probiotics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Xu, Dr. (+ 86 13671979116, xu.fei@haut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.