Alcohol AbuseNCT06607562

Effectiveness and Safety of Probiotics in Protecting Liver Function

A study testing Probiotic group in people with Alcohol Abuse, run by Wecare Probiotics Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Abuse
What is being tested?: Probiotic group
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteChina
Study dates: 3 Jun 2024to 1 Nov 2025
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 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
Voluntarily signed a written informed consent form, agreeing to participate in this study;
Agreed to comply with the study protocol and restrictions;
Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.

Who cannot join

Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
Patients with severe allergies or immune deficiencies;
Pregnant, breastfeeding, or women with plans for pregnancy;
Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
Individuals who have used antibiotics within the past two weeks;
Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
Other participants deemed unsuitable by the researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

Wu Ying
Luoyang, Henan, 471000

Other trials in China

About this study

Official title: The Improvement Effects of Weizmannia Coagulans BC99 on Liver Function and Gut Microbiota of Long-Term Alcohol Drinkers: A Randomized Double-Blind Clinical Trial

To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers

Conditions: Alcohol Abuse
Being tested: Probiotic group, Placebo group
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Probiotic groupDietary supplement
Participants received Weizmannia coagulans BC99 supplementation for 60 days. Liver function indicators were assessed before and after intervention.
Placebo groupDietary supplement
Participants received maltodextrin placebo for 60 days. Liver function indicators were assessed before and after intervention.

Study groups in NCT06607562
Study group	Role	What they receive
Probiotics group	Experimental	10B CFU/Sachet/Day Weizmannia coagulans BC99 Storage: Store in cool and dry place without sun exposure. Receives: Dietary Supplement: Probiotic group
Placebo	Placebo comparator	Maltodextrin one Sachet/Day Storage: Store in cool and dry place without sun exposure. Receives: Dietary Supplement: Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels
Change from baseline to Day 60 in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), and total bilirubin (TBil), measured using an automated biochemical analyzer.
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 20241 Nov 2025

First posted23 Sep 2024
Study start3 Jun 2024
Primary completion15 Nov 2024
Study completion1 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Alcohol AbuseStudies of the same condition, open and under way.
More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
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: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06607562
Sponsor's protocol ID: WK2024012
Status last verified: Jul 2026
First submitted: 11 Sep 2024
Last updated: 30 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Improvement Effects of Weizmannia Coagulans BC99 on Liver Function and Gut Microbiota of Long-Term Alcohol Drinkers: A Randomized Double-Blind Clinical Trial
ClinicalTrials.gov ID: NCT06607562
Acronym / sponsor ID: WK2024012
Conditions: Alcohol Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Jun 2024 (actual)
Primary completion: 15 Nov 2024 (actual)
Study completion: 1 Nov 2025 (actual)
First posted: 23 Sep 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.

To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Probiotics group	Experimental	Dietary Supplement: Probiotic group10B CFU/Sachet/Day Weizmannia coagulans BC99 Storage: Store in cool and dry place without sun exposure.
Placebo	Placebo comparator	Dietary Supplement: Placebo groupMaltodextrin one Sachet/Day Storage: Store in cool and dry place without sun exposure.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
Voluntarily signed a written informed consent form, agreeing to participate in this study;
Agreed to comply with the study protocol and restrictions;
Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.

Key exclusion criteria (8 listed)

Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
Patients with severe allergies or immune deficiencies;
Pregnant, breastfeeding, or women with plans for pregnancy;
Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;

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
Probiotic groupParticipants received Weizmannia coagulans BC99 supplementation for 60 days. Liver function indicators were assessed before and after intervention.	Dietary supplement	Probiotics group
Placebo groupParticipants received maltodextrin placebo for 60 days. Liver function indicators were assessed before and after intervention.	Dietary supplement	Placebo

Primary outcome

Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels
Time frame: 60 days
Change from baseline to Day 60 in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), and total bilirubin (TBil), measured using an automated biochemical analyzer.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Individual participant dataSharing planned: No

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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.

Ying Wu, Dr. study chair

Henan University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic group in people with Alcohol Abuse, run by Wecare Probiotics Co., Ltd. at 1 site in China.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06607562.

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 30 Jul 2026.