Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorZhujiang Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Monoclonal gammopathy patients without concurrent infection
Group B: Monoclonal gammopathy patients with concurrent infection
Group C: Healthy control group
Trial outcomes
Primary outcomes
1
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.
Time frame
24 months2
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.
Time frame
24 months3
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.
Time frame
24 months4
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov