Gut Bacteria and Immune Function in People With Monoclonal Gammopathy and Infection
Compares gut bacteria and immune markers in people with monoclonal gammopathy, with or without infection.
Plain-language title generated from the registry record
Registry title: Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
Key facts
- Where
- Guanzhou, ChinaSee the site
Where in China
- Zhujiang Hospital of Southern Medical UniversityGuanzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhujiang Hospital
- Trial code
- NCT06539832
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
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.
Inclusion: 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.
Exclusion: 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.