NCT05190848Recruiting
Correlation of Microbiome and Metabonomics With IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 27 Dec 2021
- Start date
- 1 May 2020
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- IgA nephropathy
- NCT number
- NCT05190848
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 May 2020 to the primary completion date, 1 Dec 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives
Other illness
- Type I or type II diabetes
- 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
Other
- Pregnancy and menstrual period
Who the study is looking for
- (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
Age in the registry: 16 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Third Affiliated Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.