Actively Recruiting
Gut Microbiota Profiling in Patients With Monoclonal Gammopathy Implications for Disease Mechanisms and Progression
Led by Zhujiang Hospital · Updated on 2024-12-27
2990
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational case-control study to analyze the gut microbiome characteristics in patients with monoclonal gammopathy of undetermined significance (MGUS). The study aims to identify abnormal features of the gut microbiome in MGUS patients, which may help find new biomarkers and understand potential mechanisms for diagnosis, prognosis, and treatment of MGUS. It also explores the impact of common comorbidities on gut microbiome structure and disease progression in monoclonal gammopathy patients. Participants will provide whole blood, plasma, serum, and stool samples at enrollment. Samples will come from MGUS patients, non-MGUS patients with similar diseases, and healthy controls matched by age and gender. A total of 2,990 samples will be collected from 11 disease categories and healthy controls. The study will perform multi-omics analyses including microbiomics, proteomics, peptidomics, serum biochemical, and immunological tests to examine microbiome characteristics and clinical outcomes. During the study, participants will provide demographic, lifestyle, family medical history, and medication information. Researchers will measure M-protein detection, microbiome profiles, and metabonomics over 24 months. The study aims to identify key microbial biomarkers and compare microbiome structures and clinical lab results between MGUS and other groups. The total involvement includes sample collection, data analysis, and long-term monitoring of microbiome and disease progression.
CONDITIONS
Official Title
Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older
- Negative screening for monoclonal protein by MALDI-TOF MS
- No significant diseases found upon medical examination and no diseases related to this study
- Sufficient whole blood, plasma, serum, and stool samples available with relevant case data
You will not qualify if you...
- History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease
- Antibiotic treatment 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China, 510280
Actively Recruiting
Research Team
N
Nianyi Zeng
H
Hongwei Zhou, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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