Exploring the link between gut bacteria and IgA Nephropathy
Correlation of Microbiome and Metabonomics With IgA Nephropathy
Guangdong Provincial People's Hospital · NCT05190848
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital (other) |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT05190848 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with confirmed IgAN who have not received certain treatments in the past six months.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IgA Nephropathy, IgAN microbiome metabolite