Actively Recruiting
Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
Led by Zhujiang Hospital · Updated on 2024-09-19
300
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between the gut microbiota and immune function in patients with monoclonal gammopathy, a condition that can lead to multiple myeloma, especially when complicated by infections. This observational study includes 200 patients diagnosed by MALDI-TOF MS, half of whom have infections, along with 100 healthy individuals matched by age and gender. The goal is to understand how changes in gut bacteria and immune markers relate to infection risks in these patients. Participants are grouped into monoclonal gammopathy patients with infections, without infections, and healthy controls. Researchers will analyze blood and stool samples to compare gut microbiota composition and immune function indicators, such as immune cell profiles and cytokine levels. The study uses a retrospective cohort design to explore these correlations, aiming to provide insights for future prevention and treatment of infections in monoclonal gammopathy. During the study, participants provide blood, plasma, and stool samples, and their clinical data are reviewed. Researchers will assess microbiome changes, immune function, M-protein presence, and metabolic profiles over 24 months. The study involves careful monitoring of infection markers and immune status to better understand disease progression and immune balance in these patients.
CONDITIONS
Brief Title
Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years and older
- Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening
- No symptoms of infection and normal infection indicators (whole blood hs-CRP, serum IL-6, PCT)
- Sufficient remaining whole blood, plasma, and stool samples available
- Relevant case information can be provided
You will not qualify if you...
- History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization
- Received antibiotic treatment in the past one month
- 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)
Duration - Up to 24 months
Participants provide blood, plasma, and stool samples to analyze gut microbiota and immune function characteristics.
Multiple assessments over 24 months
Duration - Up to 24 months
Participants are observed over time to monitor gut microbiota, immune function, and metabolic profiles without receiving active treatment.
Follow-up visits as scheduled over 24 months
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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