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Correlation of Microbiome and Metabonomics With IgA Nephropathy
Led by Guangdong Provincial People's Hospital · Updated on 2025-03-12
600
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
IgA Nephropathy (IgAN) is the most common primary glomerulonephritis in China, marked by deposits of a specific antibody called galactose-deficient IgA1 in the kidney. This antibody is thought to originate from mucosa-associated lymphoid tissue and is triggered by bacteria exposure. Researchers are exploring how the microbes in the mouth and throat relate to IgAN since this link is currently unclear. The study aims to develop a model using mucosa-specific microbes and clinical data to aid early diagnosis and gain insights into potential treatments for IgAN. This observational study will enroll IgAN patients who have not used glucocorticoids, immunosuppressants for six months, or antibiotics for one month, along with their family members. Samples including feces, urine, blood, oral mucosal swabs, and throat swabs will be collected for analysis of microbial and metabolic profiles. Additional samples will be gathered from IgAN patients at two and six months to monitor changes in bacterial communities and metabolites in relation to disease progression. Participants will undergo multiple sample collections over time to assess microflora and metabolite changes. Researchers will analyze these data alongside clinical indicators to understand disease development better. The primary measures include counting participants with any cause of death or those who do not meet entry criteria within six months after enrollment. The study duration and follow-up continue for at least six months, with safety and disease status monitored throughout.
CONDITIONS
Brief Title
Correlation of Microbiome and Metabonomics With IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed IgA Nephropathy by kidney biopsy
- Age 16 to 65 years
- No antibiotics, probiotics, or prebiotics use for at least one month before sampling
- No glucocorticoid or immunosuppressant treatment in the six months before sampling
- No significant changes in diet or medication for at least one month
- No other immune or autoimmune diseases such as lupus
- Signed informed consent
You will not qualify if you...
- Type I or type II diabetes
- Pregnancy or menstrual period
- Mental illness or inability to complete follow-up
- Medically diagnosed intestinal diseases such as irritable bowel syndrome or inflammatory bowel disease
- Viral hepatitis or other infectious diseases
- Use of laxatives including polyethylene glycol electrolyte dispersant or enema in the month before specimen collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial sampling and follow-up sampling at 2 and 6 months
Participants provide biological samples including feces, urine, blood, oral mucosal swabs, and pharyngeal swabs for microbiome and metabolite analysis.
3 visits (in-person) at baseline, 2 months, and 6 months
Duration - Up to 6 months after enrollment
Participants are observed to analyze the relationship between bacterial community changes, metabolite changes, and disease progression.
Participants are monitored without additional visits beyond sample collections
Trial Site Locations
Total: 5 locations
1
Sun Yat-sen Memorial Hospital Sun Yat-sen university
Guangzhou, Guangdong, China
Actively Recruiting
2
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
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3
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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4
Guangdong Provincial People's Hospital
Guanzhou, Guangdong, China
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5
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
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Research Team
X
Xueqing Yu
F
Fengtao Cai
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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