Correlation of Microbiome and Metabonomics With IgA Nephropathy

NCT05190848 | Recruiting DMC

• 1 other identifier: GDPH-IgAN-microbiome
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 5

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.

Conditions

IgA Nephropathy

Keywords

IgAN microbiome metabolite

Outcome Measures

Primary Outcomes (2)

• Number of Participants with all-cause death

  Death for any reason.

  From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months

• Number of Participants with not meet the entry criteria

  not meet the entry criteria for any reason

  From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IgA nephropathy confirmed by renal biopsy and family members living with them

You may qualify if:

• (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

You may not qualify if:

• Type I or type II diabetes
• Pregnancy and menstrual period
• Mental illness and inability to assess follow-up
• Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
• Viral hepatitis or other infectious diseases
• One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (5)

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

Biospecimen

Retention: SAMPLES WITH DNA

urine、blood、Oral swabs、Pharyngeal swab、feces

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xueqing Yu

  Guangdong Provincial People's Hospital

  STUDY CHAIR

• Xinling Liang

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Zhiming Ye

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Xueqing Yu

CONTACT

+86-20-83827812; yuxq@mail.sysu.edu.cn

Fengtao Cai

CONTACT

19860209072; fengtaoc@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 13, 2022
• Study Start: May 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (5)