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Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy

Recruitingn/aAges 45 Years - anyAllZhujiang Hospital
NCT06690593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.

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📋 Eligibility rules (as published)
(I) Inclusion Criteria: 1. Age 45 years or older; 2. Negative screening for monoclonal protein by MALDI-TOF MS; 3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study; 4. Sufficient whole blood, plasma, serum, 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. Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
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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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