Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients:A Clinical Trial

Probiotic Supplementation With BLa80, BL21, and LRa05 Stabilizes Lipid Metabolism in Chronic Hepatitis B Patients Receiving Tenofovir Alafenamide: A Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06221605

Enrollment

Registered

2024-01-24

Start date

2024-03-30

Completion date

2025-04-11

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

The goal of this is to verify the clinical efficacy of compound probiotics in reducing HBV infection levels and regulating intestinal flora in patients with chronic hepatitis B. The main question it aims to answer is: • Conventional antiviral therapy combined with a 3-month probiotic intervention was used to evaluate the clinical efficacy of reducing HBV infection levels (HBeAg, HBsAg, and HBV DNA levels) and regulating gut microbiota.

Interventions

DIETARY_SUPPLEMENTProbiotic

The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Double (Participant, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

1. Meet the hepatitis B clinical diagnostic criteria of the Chronic Hepatitis B Prevention and Treatment Guidelines (2022 edition), excluding patients infected with hepatitis C virus, hepatitis D virus and other hepatitis viruses; 2. Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

Exclusion criteria

1. Patients infected within 3 months; 2. Received antibiotic treatment within 3 months; 3. Received probiotic and probiotic therapy within 3 months; 4. Complicated with hypertension or diabetes; 5. Obesity or significantly low weight; 6. Obvious atherosclerosis; 7. Chronic kidney disease; 8. Inflammatory bowel disease, irritable bowel syndrome, or a history of gastrointestinal surgery; 9. Malignant tumors; 10. Autoimmune diseases; 11. Mental illnesses such as Parkinson's disease, Alzheimer's disease and stroke; 12. Pregnant or lactating women; 13. Patients with cirrhosis or decompensated liver disease; 14. Subjects cannot participate in the experiment due to their reasons; Those who meet any of the above criteria will not be selected.

Design outcomes

Primary

Measure	Time frame	Description
Test the level of HBV infection in chronic hepatitis B patients	6 months	Evaluate HBsAg level in IU/mL

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026