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Multiomics analysis of the gut-liver axis on the response differences in patients with chronic hepatitis B treated with long-acting interferon combined with NAs

Multiomics analysis of the gut-liver axis on the response differences in patients with chronic hepatitis B treated with long-acting interferon combined with NAs

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124644
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Chronic Hepatitis B

Interventions

Observation group:None

Sponsors

Guabgzhou First People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients with chronic hepatitis B aged 18 to 65; 2.After 12 months or more of NAs treatment, HbsAg< 10,000 IU/ml, HbeAg negative, HBV-DNA<100IU/ml; 3.First reception of interferon combined with NAs treatment; 4.Good compliance and voluntary signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Co-infection with other hepatotropic viruses (such as hepatitis A, C, D, and E viruses). 2.Presence of other liver diseases caused by factors like alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury. 3.Severe conditions affecting the heart, kidneys, hematopoietic system, or malignant tumors. 4.Women who are pregnant or breastfeeding. 5.Use of antibiotics, probiotics, immunomodulators, or other medications that may affect gut microbiota and liver function within the past 3 months. 6.All participants with easily confused diseases have been excluded from this study, and the number of relevant confounding cases is 0.

Design outcomes

Primary

MeasureTime frame
HBsAg level;

Secondary

MeasureTime frame
16S rRNA indicators(flora a diversity (Shannon, Chao1 index), ß diversity, and differential genus abundance);Metabolomics indicators(Differential metabolite concentrations (e.g., short-chain fatty acids, bile acids, amino acids));ELISA detection index(serum inflammatory cytokines (IL-6, TNF-a, IL-10, TGF-ß) concentration);microRNA indicators(the relative expression levels of differentially expressed microRNAs (e.g., miR-122, miR-155));

Countries

China

Contacts

Public ContactQi Zhan

Guabgzhou First People‘s Hospital

zhanqi96@163.com+86 20 81048012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026