Clinical trial NCT05190848: Correlation of Microbiome and Metabonomics With IgA Nephropathy
Official title: Correlation of Microbiome and Metabonomics With IgA Nephropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgA Nephropathy
Keywords: IgAN microbiome metabolite
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IgA nephropathy confirmed by renal biopsy and family members living with them

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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants with all-cause death
timeFrame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
measure: Number of Participants with not meet the entry criteria
timeFrame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital Sun Yat-sen university
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guanzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guanzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Xueqing Yu
role: STUDY_CHAIR
affiliation: Guangdong Provincial People's Hospital
name: Xinling Liang
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Zhiming Ye
role: STUDY_DIRECTOR
References: