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

NCT06221605 | Completed

• 1 other identifier: WK2023009
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Test the level of HBV infection in chronic hepatitis B patients

  Evaluate HBsAg level in IU/mL

  6 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

30 billion CFU/sachet/day, before meals; Compound Probiotics (Bifidobacterium animalis subsp. animalis BLa80、Bifidobacterium longum subsp. longum BL21、Lacticaseibacillus rhamnosus LRa05) Storage: store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

placebo

PLACEBO COMPARATOR

Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic group; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

You may not qualify if:

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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated with Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 24, 2024
• Study Start: March 30, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 11, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)