Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

NCT06539832 | Recruiting

• 1 other identifier: ZhujiangMGUS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; MGUS; Gut Microbiota; Infections; M-Protein

Outcome Measures

Primary Outcomes (4)

• M-protein detection

  Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.

  24 months

• microbiome

  To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.

  24 months

• immunological function

  To assess the number and function of peripheral blood immune cells (T-cells, B-cells, NK-cells, etc.) in patients with monoclonal gammaglobulinaemia. To further investigate the potential therapeutic value of intestinal microecological modulation in improving the immune status of MGUS patients.

  24 months

• metabonomics

  To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.

  24 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Monoclonal gammopathy negative as determined by MALDI-TOF MS screening. 2. No symptoms of infection and normal levels of inflammatory markers (whole blood hs-CRP, serum IL-6, PCT). 3. Availability of sufficient remaining whole blood, plasma and fecal samples, as well as relevant case information. Patients will be excluded if they have: 1. A previous history of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease. 2. Received antibiotic therapy within the last month. 3. Severe systemic diseases, including malignant tumors. Insufficient sample volume or presence of sample failure (e.g. severe hemolysis, lipemia or jaundice).

You may qualify if:

• 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.

You may not qualify if:

• Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and
• Patients receiving antibiotic therapy in the last month
• Severe systemic diseases including malignant tumours;
• Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Infections

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hongwei Zhou, Professor

  Southern Medical University, China

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Hongwei Zhou, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 6, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)