RecruitingNCT06539832

Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection

Sponsor

Zhujiang Hospital

Enrollment

300 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Multiple Myeloma Infections MGUS Gut Microbiota M-Protein

Summary

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.

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring the relationship between gut bacteria (intestinal flora) and the immune system in people with monoclonal gammopathy — a condition where abnormal proteins are found in the blood, which can sometimes be a precursor to blood cancers like multiple myeloma. Researchers want to understand whether gut microbiome differences play a role in disease progression. **You may be eligible if...** - You are 45 or older - You have tested negative for monoclonal proteins by a specific screening method (MALDI-TOF MS) - You have no signs of active infection and your infection markers are normal - You have sufficient blood, plasma, and stool samples available for testing **You may NOT be eligible if...** - You have a history of intestinal cancer, irritable bowel syndrome, or inflammatory bowel disease - You have taken antibiotics in the past month - You have severe systemic illnesses including other cancers - Sufficient sample volume is not available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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