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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221605
• Other study ID #: WK2023009
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Dietary Supplement:
• Probiotic
The intervention lasted for 6 months and 3 visits (at 0 month, 3rd and 6th month respectively).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Outcome

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