Study of Gut Microbiome Changes in Patients Aged 45 and Older With Monoclonal Gammopathy and Related Conditions

What this Trial Is About

Researchers are investigating the gut microbiome in patients with monoclonal gammopathy of undetermined significance MGUS through an observational case-control study. The study aims to analyze the gut microbiome characteristics of MGUS patients compared to non-MGUS patients with similar diseases and healthy controls. This research seeks to identify new biomarkers and understand potential mechanisms for diagnosing, evaluating prognosis, and developing treatment strategies for MGUS. The study collects blood and stool samples from participants across 11 disease categories, including MGUS and non-MGUS groups, along with healthy age- and gender-matched controls. Samples undergo multi-omics analyses such as microbiomics, peptidomics, proteomics, serum biochemical, and immunological tests. A total of 2,990 samples are collected to explore associations between gut microbiome features and clinical outcomes, comparing microbiome structures and laboratory indices among different groups. Participants provide demographic, lifestyle, family medical history, and medication information at enrollment. Samples include whole blood, plasma, serum, and feces. Researchers will monitor M-protein detection, microbiome profiles, and metabonomics over 24 months. This comprehensive evaluation aims to clarify gut microbiome dysbiosis in MGUS and assess its impact on disease progression, with study participation occurring across this timeframe.

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