Correlation of Microbiome and Metabonomics With IgA Nephropathy

NCT ID: NCT05190848

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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IgAN-microbiome is an investigator-initiated,multi-center,Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.

Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.

Conditions

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IgA Nephropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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XueQing Yu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xueqing Yu

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Xinling Liang

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Zhiming Ye

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Locations

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Sun Yat-sen Memorial Hospital Sun Yat-sen university

Guangzhou, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guanzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guanzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xueqing Yu

Role: CONTACT

+86-20-83827812

Fengtao Cai

Role: CONTACT

19860209072

Facility Contacts

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Qiongqiong Yang

Role: primary

Ying Tang

Role: primary

Hui Peng

Role: primary

Xueqing Yu

Role: primary

+86-20-83827812

Guangdong Provincial People's Hospital Cai

Role: backup

Other Identifiers

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GDPH-IgAN-microbiome

Identifier Type: -

Identifier Source: org_study_id

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