Actively Recruiting
Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
Led by Zhujiang Hospital · Updated on 2024-12-27
2990
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 provided
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for sample collection and information gathering
Duration - At enrollment
Participants provide whole blood, plasma, serum, and fecal samples, and relevant demographic, lifestyle, family medical history, and medication information is collected.
1 visit (in-person)
Duration - Up to 24 months
Participants are observed over time to analyze gut microbiome characteristics and their association with clinical outcomes related to monoclonal gammopathy and comorbidities.
No scheduled visits; data collected through observational follow-up
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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