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Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Recruitingn/aAges 45 Years - anyAllZhujiang Hospital
NCT06539832 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 provid

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 45 years and older; and 2. Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening; 3. No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT); 4. Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided. Exclusion Criteria: 1. Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and 2. Patients receiving antibiotic therapy in the last month 3. Severe systemic diseases including malignant tumours; 4. Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.
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What it tests

  • Not listed
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Where

1 site
Zhujiang Hospital of Southern Medical University
Guanzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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