Analyzing gut microbiota in patients with monoclonal gammopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational case-control study aims to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). It will collect blood and stool samples from MGUS patients, non-MGUS patients with similar diseases, and healthy controls, totaling nearly 3,000 samples. The study will utilize multi-omics detection methods, including microbiomics and biochemical immunology, to identify abnormal features of the gut microbiome in MGUS patients. The findings may lead to new biomarkers and insights into the diagnosis and treatment strategies for MGUS.

Why it matters

Who can join: the full rules

(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.

Where it's running

• Zhujiang Hospital of Southern Medical University
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Nianyi Zeng
• Email: zengny1@i.smu.edu.cn
• Phone: 13928801657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.