Exploring the link between gut bacteria and IgA Nephropathy
Official title: Correlation of Microbiome and Metabonomics With IgA Nephropathy
Run by Guangdong Provincial People's Hospital · NCT05190848 · Data updated 2026-11-12
This study is trying to see how gut bacteria and their byproducts affect people with IgA Nephropathy to help improve early diagnosis and treatment of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 65 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | May 1, 2020 |
| Main results expected | December 1, 2024 |
| Study ends | December 31, 2027 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT05190848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 16 and older with confirmed IgAN who have not received certain treatments in the past six months.
✕Probably not a fit
Patients with secondary causes of IgAN or those with significant comorbidities such as diabetes or active infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between the microbiome and metabolites in patients with IgA Nephropathy (IgAN), a common kidney disease in China. It aims to collect samples from patients and their family members, including feces, urine, blood, and oral swabs, to analyze the microbial communities and their metabolites. By examining changes in these samples over time, the study seeks to develop a model that could aid in the early diagnosis and treatment of IgAN. Participants must meet specific criteria, including no recent use of antibiotics or immunosuppressants.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment strategies for patients with IgA Nephropathy.
How similar studies have gone: While the relationship between microbiome and autoimmune diseases is being explored, this specific approach to IgAN is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Sun Yat-sen Memorial Hospital Sun Yat-sen university
Guangzhou, Guangdong, China Recruiting -
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting -
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Guangdong Provincial People's Hospital
Guanzhou, Guangdong, China Recruiting -
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xueqing Yu
- Email: yuxq@mail.sysu.edu.cn
- Phone: +86-20-83827812
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JADE101 in IgA Nephropathy: a Phase 2 test in adults
This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.
-
Atrasentan for pediatric primary IgA nephropathy
This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.
-
Anti-CD19/BCMA universal CAR-T (RD06-05) for autoimmune diseases
This early-phase test gives a universal CAR-T therapy (RD06-05) that targets CD19 and BCMA to adults with autoimmune diseases such as SLE/lupus nephritis, ANCA-associated vasculitis, and anti-GBM disease.
-
BHV-1400 for IgA nephropathy
This study will try BHV-1400 in adults with biopsy-confirmed IgA nephropathy to see if the drug is safe and tolerable.
-
Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria
This test will see if combining Nefecon (a gut‑targeted budesonide) with ambrisentan can reduce urine protein and slow kidney decline in adults with IgA nephropathy who have at least 0.5 g of protein in a 24‑hour urine collection.
-
Epithelial Dysmetabolism and Kidney Fibrosis in ANCA Vasculitis
This study tests whether alterations in tubulo-interstitial metabolism relate to how quickly kidney function deteriorates in people with ANCA-associated vasculitis compared to other nephropathies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.