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Characterization of intestinal microbiota in patients with metabolic fatty liver disease (MAFLD) and mechanistic study of its bile acid-FXR axis

Characterization of intestinal microbiota in patients with metabolic fatty liver disease (MAFLD) and mechanistic study of its bile acid-FXR axis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089346
Enrollment
Unknown
Registered
2024-09-06
Start date
2022-10-27
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Metabolic-related fatty liver disease

Interventions

Sponsors

Wuxi Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the health group: (1) Age: 18-60 years old; (2) No gender restrictions; (3) Patients who have signed informed consent forms. (4) FAP240 db/m, and the diagnosis conforms to the International Expert Consensus on Metabolic Related Fatty Liver Disease (2020);

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy population group: (1) Those who do not meet the inclusion criteria; (2) Individuals under the age of 18 or over 60 years old; (3) Used antibiotics within one month prior to enrollment and refused to discontinue medication for elution; Currently, patients taking probiotics, gastrointestinal motility drugs, and other preparations that can affect gut microbiota; (4) There are contraindications for fibrotouch and colonoscopy examination; (5) Patients with mental or legal disabilities; (6) Women of childbearing age who are preparing to become pregnant during the study period; (7) Patients with severe diseases of important organs such as heart, brain, lungs, liver, and kidneys; (8) The patient participated in other clinical trials within 3 months; (9) Researchers believe that other patients are not suitable for inclusion. Exclusion criteria for fatty liver group: (1) Those who do not meet the inclusion criteria; (2) Individuals under the age of 18 or over 60 years old; (3) Alcohol consumption history>5 years, equivalent to ethanol intake = 40g/d for males and = 20g/d for females; Or have a history of heavy alcohol consumption within 2 weeks, equivalent to an ethanol level greater than 80g/d; (4) Specific diseases that can lead to fatty liver, such as viral hepatitis, drug-induced liver disease, genetic factors, etc; (5) Used antibiotics within one month prior to enrollment and refused to discontinue medication for elution; Currently, patients taking probiotics, gastrointestinal motility drugs, and other preparations that can affect gut microbiota; (6) There are contraindications for fibrotouch and colonoscopy examination; (7) Patients with mental or legal disabilities; (8) Women of childbearing age who are preparing to become pregnant during the study period; (9) Patients with severe diseases of important organs such as heart, brain, lungs, liver, and kidneys; (10) The patient participated in other clinical trials within 3 months; (11) Researchers believe that other patients are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
liver ultrasound fibroscan ;liver function;16s rDNA sequencing of intestinal microbiota;

Countries

China

Contacts

Public ContactWei Taotao

Wuxi Hospital of Traditional Chinese Medicine

383401938@qq.com+86 186 2635 0312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026