Regulation of Intestinal Flora by Compound Probiotics in Patients With Chronic Hepatitis B

Regulation of Intestinal Flora by Compound Probiotics in Patients With Chronic Hepatitis B: a Randomized, Double-blind, Placebo-controlled Study

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 6-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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 15B 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; The intervention lasted for 6 months and 3 visits (at 0 month, 3rd and 6th month respectively).
Placebo Comparator: placebo; Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.	Dietary supplement: Probiotic; The intervention lasted for 6 months and 3 visits (at 0 month, 3rd and 6th month respectively).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: WK2023009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No