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

Status: Recruiting

Location: See location...

Study Type: Observational

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

Participation Requirements

Sex: All

Minimum Age: 45

Healthy Volunteers: t

View:

• Age 45 years and older; and

• Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening;

• No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT);

• Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided.

Locations

Other Locations

China

Zhujiang Hospital of Southern Medical University

RECRUITING

Guanzhou

Contact Information

Primary

Nianyi Zeng

zengny1@i.smu.edu.cn

13928801657

Backup

Hongwei Zhou, Professor

Time Frame

Start Date: 2024-05-01

Estimated Completion Date: 2026-12-30

Participants

Target number of participants: 300

Treatments

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.

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.

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.

Related Therapeutic Areas

Multiple Myeloma

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