RecruitingNCT06690593

Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy

Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression


Sponsor

Zhujiang Hospital

Enrollment

2,990 participants

Start Date

Dec 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.


Eligibility

Min Age: 45 Years

Inclusion Criteria4

  • Age 45 years or older;
  • Negative screening for monoclonal protein by MALDI-TOF MS;
  • No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study;
  • Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided.

Exclusion Criteria3

  • History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization;
  • Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors;
  • Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.

Locations(1)

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China

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NCT06690593


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