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Correlation analysis of intestinal flora and its metabolites with abnormal bone metabolism in primary biliary cholangitis

Correlation analysis of intestinal flora and its metabolites with abnormal bone metabolism in primary biliary cholangitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036227
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Primary Biliary Cholangitis, PBC

Interventions

PBC group vs. healthy control group:Nil

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years old; 2. Gender: men and women are not limited; 3. Patients who are clinically diagnosed as PBC must meet two of the following diagnostic criteria: (1) Alkaline phosphatase (ALP) >= 2 times the upper limit of normal value or glutamine transferase (GGT) >= 5 times the upper limit of normal value; (2) Positive anti-mitochondrial antibody (AMA); (3) The liver histology showed non-purulent destructive cholangitis.

Exclusion criteria

Exclusion criteria: 1. Viral hepatitis; 2. Drug-induced hepatitis; 3. Alcoholic hepatitis; 4. Non-alcoholic fatty liver disease/inflammation; 5. Inherited metabolic liver disease; 6. Other autoimmune liver diseases except PBC: AIH, PSC, IgG4-related cholangitis, overlap syndrome, etc.; 7. Systemic autoimmune diseases affect the liver; 8. Hepatobiliary parasite infection; 9. Serious systemic diseases; 10. Decompensated liver cirrhosis, co-infection, hepatic encephalopathy, abdominal effusion, gastrointestinal bleeding, liver cancer, etc.; 11. Serious infection; 12. Tumor; 13. Primary parathyroid disease; Primary thyroid disease; Dwarfism; Pituitary tumor; 14. Long-term use of drugs that affect bone metabolism: such as glucocorticoids, calcium, sex hormones, etc.;

Design outcomes

Primary

MeasureTime frame
The correlation between the distribution characteristics of intestinal flora and bone metabolism disorders in PBC patients;

Countries

China

Contacts

Public ContactXu Jie

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University

dr.xu@aliyun.com+86 13501722091

Outcome results

None listed

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