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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

From the registry’s dates

  • Started May 2020; still recruiting 6 years 6 months later.
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

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 600 is above the median of 245 across 45 observational studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (1) Pathological changes of IgAN were confirmed by renal (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, infection and 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 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 diseases, such as systemic lupus erythematosus (8) Signed

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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

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

07

Study locations

5 of 5 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05190848
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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