This is an observational case-control study, aiming to systematically analyze the gutmicrobiome characteristics of patients with monoclonal gammopathy of undeterminedsignificance (MGUS). The study will collect blood and stool samples from MGUS patients,non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omicsdetection including microbiomics, peptidomics, and biochemical immunology. It willcomprehensively 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.
This is a case-control, observational single-center study aiming to investigate the
impact of common comorbidities on gut microbiome structure and disease progression in
patients with monoclonal gammopathy. We plan to collect samples from 11 disease
categories, with each category including two groups (monoclonal gammopathy and
non-monoclonal gammopathy), as well as 700 age- and gender-matched healthy controls, for
a total of 2,990 samples. At enrollment, we will collect whole blood, plasma, serum, and
fecal samples from the study participants, and obtain relevant information such as
demographic characteristics, lifestyle, family medical history, and medication use.We
will perform metagenomic, proteomic, and serum biochemical and immunological analyses on
the samples to directly obtain association data between gut microbiome characteristics
(as exposure factors) and clinical outcomes (as endpoints). This study will
systematically analyze the dysbiosis characteristics of the gut microbiome in monoclonal
gammopathy patients, identify key microbial biomarkers, and compare the microbiome
structure and clinical laboratory indices between MGUS patients and different comorbidity
subgroups, to explore their impact on the disease diagnostic model.
(I) Inclusion Criteria:
1. Age 45 years or older;
2. Negative screening for monoclonal protein by MALDI-TOF MS;
3. No significant diseases found upon medical examination, and confirmed not to have
any diseases related to this study;
4. Sufficient whole blood, plasma, serum, and stool samples available, and relevant
case data can be provided.
(II) Exclusion Criteria:
1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel
disease, or diagnosed during hospitalization;
2. Antibiotic treatment received in the past month; Presence of severe systemic
diseases, including malignant tumors;
3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or
other unqualified sample conditions.
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China
Investigator: Hongwei Zhou, Professor
Contact: 186 8848 9622
hzhou@smu.edu.cn
Nianyi Zeng
13928801657
zengny1@i.smu.edu.cn
Hongwei Zhou, Professor
Hongwei Zhou, Professor, Study Chair
Southern Medical University, China