Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Sponsor
Zhujiang Hospital
Study ID
NCT06539832
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Study Details

This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had concurrent infections and 100 did not. An additional 100 healthy controls, matched for age and gender, were also enrolled.By comparing the composition of the gut microbiota and immune function markers (such as peripheral blood immune cell profiles and cytokine levels) between the patient groups and the control group, the study will evaluate the dysbiosis of the gut microbiota and abnormal immune status in patients with monoclonal gammopathy complicated by infection. The aim is to explore the correlation between the gut microbiome alterations and immune dysfunction, in order to provide a basis for further investigation of the underlying mechanisms.

Key Dates

First listed
Aug 6, 2024
Start date
May 1, 2024
Status verified
May 2024
Primary completion
May 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Monoclonal gammopathy patients without concurrent infection
    (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma 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. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions.
  • Arm: Monoclonal gammopathy patients with concurrent infection
    (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. Presence of infection symptoms, with abnormal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma 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. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions.
  • Arm: Healthy control group
    (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened negative for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma 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. Received antibiotic treatment in the past one month; 3. Severe systemic diseases including malignant tumors; 4. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions.

Primary Outcome Measure

M-protein detection [ Time Frame: 24 months ]

Central Contacts

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