Chronic Hepatitis B
Conditions
Interventions
Experimental Group 1:Standard treatment (peginterferon therapy) plus oral intestinal microbiota lyophilized powder, or microbiota transplantation via nasojejunal tube or t
Control group:Standard Treatment Group (Peginterferon Therapy)
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Disease Diagnosis: Chronic viral hepatitis B was diagnosed in accordance with the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) issued by the Society of Infectious Diseases and the Society of Hepatology of the Chinese Medical Association, as well as the Chinese Expert Consensus on Clinical Practice for Functional (Clinical) Cure of Chronic Hepatitis B (2025 Edition).Inclusion criteria included: baseline negative HBeAg and serum HBsAg > 1500 IU/mL; undetectable HBV DNA after nucleos(t)ide analogue (NA) therapy; HBV DNA below the lower limit of detection (ultrasensitive) or baseline HBV DNA < 1000 IU/mL in treatment-naïve patients; 2.Confirmed diagnosis of CHB for at least 6 months; aged 18 to 70 years with stable vital signs; previously healthy; 3.Ability to communicate effectively with investigators. After understanding the study procedures and potential risks, participants voluntarily enroll in the trial and sign the Informed Consent Form approved by the Ethics Committee prior to any protocol-required assessments; 4.No significant reduction in HBsAg (<1 log10) after regular interferon therapy for 24 weeks. 5.Willing to undergo relevant procedures including visualization-guided jejunal feeding tube placement, oral capsule administration, and TET.
Exclusion criteria
Exclusion criteria: 1.Confirmed coinfection with hepatitis C, bacteria, fungi, viruses (excluding hepatitis B and D), atypical pathogens, and other types of infections;Comorbid autoimmune liver disease, Wilson's disease, alcoholic liver disease, non-alcoholic fatty liver disease, and acute hepatitis A and E (in active phase); 2.Unstable vital signs (heart rate > 120 beats/min, blood pressure 30 breaths/min); bleeding tendency (platelet count 180 mmHg or diastolic blood pressure > 110 mmHg; acute cerebral infarction; acute cerebral hemorrhage; cardiac valve replacement within the past 3 months); patients diagnosed with liver cirrhosis; renal disease (chronic kidney disease stage IV–V); endocrine and metabolic disorders (diabetic ketoacidosis or hyperosmolar state; poorly controlled diabetes; HbA1c > 9.0% with daily blood glucose fluctuation > 5.5 mmol/L; pituitary tumor, hyperthyroidism, etc.); or trauma (acute injury phase; within 2 weeks before or after surgery). Patients with well-controlled symptoms may be considered for enrollment after evaluation by the expert panel (e.g., patients with intermittent claudication due to cerebral infarction); 5.Patients who cannot receive live bacterial microbiota preparations due to restrictions from peptic ulcer or reflux esophagitis; 6.Patients diagnosed with any malignant tumor;patients with uncontrolled autoimmune diseases involving the gastrointestinal tract (such as untreated systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, etc.); 7.Patients and their family members are unwilling to participate or unable to complete the follow-up process; 8.Immune and allergic constitution: Allergic to the components of the microbial preparation, with a history of severe immune reactions, or long-term use of high-dose immunosuppressants and related biological agents; Patients with congenital or acquired immunodeficiency diseases; 9.Children, pregnant women, and lactating women; patients with a confirmed diagnosis of psychiatric disorders; patients aged over 70 years; 10.Severely immunosuppressed individuals (white blood cell count < 1.0×10^9/L or absolute neutrophil count < 0.5×10^9/L); 11.Contraindications associated with intestinal diseases:Patients with severely impaired intestinal barrier due to various causes (such as sepsis, active massive gastrointestinal bleeding, or perforation);patients currently diagnosed with fulminant colitis or toxic megacolon;and patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, ulcerative colitis, Crohn’s disease, intestinal fistula, or other conditions; 12.Patients with a reduction in HBsAg greater than 1 log10 after regular interferon therapy;patients with severe malnutrition (BMI < 15) or fecal incontinence; 13.Other conditions deemed unsuitable for enrollment by the investigators,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg seroconversion rate and HBsAb level;Liver fibrosis level;Determination of gut microbiota diversity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of hepatic inflammation (if the patient consents);Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactJiabin Li
The first affiliated hospital of anhui medical university
Outcome results
None listed