Correlation of Microbiome and Metabonomics With IgA Nephropathy

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Brief Title

Correlation of Microbiome and Metabonomics With IgA Nephropathy

Official Title

Correlation of Microbiome and Metabonomics With IgA Nephropathy

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.
    


Study Type

Observational


Primary Outcome

Number of Participants with all-cause death


Condition

IgA Nephropathy



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

600

Start Date

May 1, 2020

Completion Date

December 1, 2024

Primary Completion Date

December 1, 2022

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
      

Gender

All

Ages

16 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Xueqing Yu, +86-20-83827812, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05190848

Organization ID

GDPH-IgAN-microbiome


Responsible Party

Principal Investigator

Study Sponsor

Guangdong Provincial People's Hospital


Study Sponsor

Xueqing Yu, Study Chair, Guangdong Provincial People's Hospital


Verification Date

January 2022