NCT05190848 Correlation of Microbiome and Metabonomics With IgA Nephropathy
| NCT ID | NCT05190848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangdong Provincial People's Hospital |
| Condition | IgA Nephropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-05-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2020-05-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Xueqing Yu
STUDY CHAIR
Guangdong Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT05190848 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying IgA Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05190848 currently recruiting?
Yes, NCT05190848 is actively recruiting participants. Contact the research team at yuxq@mail.sysu.edu.cn for enrollment information.
Where is the NCT05190848 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Guanzhou, China and 1 additional location.
Who is sponsoring the NCT05190848 clinical trial?
NCT05190848 is sponsored by Guangdong Provincial People's Hospital. The principal investigator is Xueqing Yu at Guangdong Provincial People's Hospital. The trial plans to enroll 600 participants.