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.
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.
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.
The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Confirmed negative for monoclonal immunoglobulin by MALDI-TOF MS screening. 2. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study. 3. Availability of sufficient whole blood, plasma, serum, and fecal samples, as well as relevant case information. Exclusion criteria include: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease. 2. Received antibiotic treatment within the last month. 3. Presence of severe systemic diseases, including malignant tumors, insufficient sample volume, or presence of sample failure (e.g., severe hemolysis, lipemia, or jaundice).
Case-control
Retrospective
Not listed
M-protein detection
Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.
microbiome
To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.
metabonomics
To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.
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