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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 3 trial groups

Sponsors and collaborators