Status:

RECRUITING

Correlation of Microbiome and Metabonomics With IgA Nephropathy

Lead Sponsor:

Guangdong Provincial People's Hospital

Conditions:

IgA Nephropathy

Eligibility:

All Genders

16-65 years

Brief Summary

IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1...

Detailed Description

IgAN-microbiome is an investigator-initiated,multi-center,Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants fo...

Eligibility Criteria

Inclusion

  • (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent

Exclusion

  • Type I or type II diabetes
  • Pregnancy and menstrual period
  • Mental illness and inability to assess follow-up
  • Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
  • Viral hepatitis or other infectious diseases
  • One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives

Key Trial Info

Start Date :

May 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT05190848

Start Date

May 1 2020

End Date

December 1 2025

Last Update

March 12 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Sun Yat-sen Memorial Hospital Sun Yat-sen university

Guangzhou, Guangdong, China

2

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

3

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

4

Guangdong Provincial People's Hospital

Guanzhou, Guangdong, China