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RecruitingNCT05190848Updated Sep 14, 2026

Correlation of Microbiome and Metabonomics With IgA Nephropathy

An observational study in IgA Nephropathy, sponsored by Guangdong Provincial People's Hospital. Recruiting at 5 sites in China. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Guangdong Provincial People's Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
600
Ages
16 Years to 65 Years
Sex
All
01

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.

Read the 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 for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.

Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.

02

Conditions studied

  • IgA Nephropathy

Keywords

  • IgAN microbiome metabolite
03

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

IgA nephropathy confirmed by renal biopsy and family members living with them

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Number of Participants with all-cause death

    Death for any reason.

    Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months

  2. Number of Participants with not meet the entry criteria

    not meet the entry criteria for any reason

    Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months

06

Study locations

5 of 5 sites recruiting
  • Sun Yat-sen Memorial Hospital Sun Yat-sen university
    Guangzhou, Guangdong, China
    • Qiongqiong Yang · Contact
    Recruiting
  • The Third Affiliated Hospital of Southern Medical University
    Guangzhou, Guangdong, China
    • Ying Tang · Contact
    Recruiting
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    • Hui Peng · Contact
    Recruiting
  • Guangdong Provincial People's Hospital
    Guanzhou, Guangdong, China
    Recruiting
  • The First Affiliated Hospital of Sun Yat-sen University
    Guanzhou, Guangdong, China
    • Wei Chen · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT05190848
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
XueQing Yu (professor, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Jan 13, 2022
Start date
May 1, 2020
Primary completion
Dec 1, 2024
Completion
Dec 31, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Xueqing Yu
Contact
yuxq@mail.sysu.edu.cn
+86-20-83827812
Fengtao Cai
Contact
fengtaoc@126.com
19860209072
Xueqing Yu
study chair · Guangdong Provincial People's Hospital
Xinling Liang
study director · Guangdong Provincial People's Hospital
Zhiming Ye
study director · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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