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Clinical Trials in China / NCT05190848
Recruiting Observational

Correlation of Microbiome and Metabonomics With IgA Nephropathy

NCT05190848 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Provincial People's Hospital
Phase
Observational
Started
2020-05-01
Last updated
2026-09-14

Condition(s) studied

IgA Nephropathy

Study 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, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.

Eligibility

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * (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 Criteria: 1. Type I or type II diabetes 2. Pregnancy and menstrual period 3. Mental illness and inability to assess follow-up 4. Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease 5. Viral hepatitis or other infectious diseases 6. One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives

Primary outcome measure(s)

  • Number of Participants with all-cause death — From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
    Death for any reason.
  • Number of Participants with not meet the entry criteria — From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
    not meet the entry criteria for any reason

Trial sites (5)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital Sun Yat-sen university Guangzhou Guangdong Recruiting
The Third Affiliated Hospital of Southern Medical University Guangzhou Guangdong Recruiting
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
Guangdong Provincial People's Hospital Guanzhou Guangdong Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guanzhou Guangdong Recruiting

More Guangdong Provincial People's Hospital trials in China

Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial Recruiting
Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study) Recruiting
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis Recruiting
Multicenter Prospective Validation of AI Models for Malignancy Risk Prediction in Pulmonary Nodules Starting soon
Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients Recruiting

Other trials for the same condition

IgA Nephropathy Biomarkers Evaluation Study (INTEREST) Recruiting
Study of CM313 in Subject With IgA Nephropathy Starting soon
A Study of Zigakibart in Adults With IgA Nephropathy Active, not recruiting
MYTP01 for Immune-Mediated Diseases Starting soon
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05190848 on ClinicalTrials.gov ↗ ← All trials in China