Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Launched by ZHUJIANG HOSPITAL · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the connection between gut bacteria and the immune system in patients with monoclonal gammopathy, which includes conditions like Multiple Myeloma and MGUS. The researchers want to see how the gut microbiota (the community of bacteria living in the intestines) and immune function are affected in patients who have infections compared to those who do not, as well as how these factors differ from healthy individuals. The study will involve 200 patients with monoclonal gammopathy, half of whom have infections, and 100 healthy participants who match the patients in age and gender.

To be eligible for this trial, participants need to be 45 years or older and must have a specific type of monoclonal gammopathy. They should not currently have any signs of infection, and their blood tests should show normal levels of infection markers. People with certain gastrointestinal diseases, those who have taken antibiotics recently, or those with severe health issues won't be able to participate. Participants can expect to provide blood and stool samples, which will help researchers learn more about how gut health and immune responses are related in these patients, potentially leading to better understanding and treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 45 years and older; and
• • 2. Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening;
• • 3. No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT);
• • 4. Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided.
• Exclusion Criteria:
• • 1. Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and
• • 2. Patients receiving antibiotic therapy in the last month
• • 3. Severe systemic diseases including malignant tumours;
• • 4. Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.