Investigating gut microbiota and immune function in monoclonal gammopathy patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines the gut microbiota characteristics and immune function in patients diagnosed with monoclonal gammopathy, particularly those with concurrent infections. It includes 200 patients, split evenly between those with infections and those without, alongside 100 healthy controls matched for age and gender. By analyzing the composition of gut microbiota and immune markers, the study aims to uncover correlations between microbiome alterations and immune dysfunction, providing insights into the underlying mechanisms affecting these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhujiang Hospital of Southern Medical University
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Nianyi Zeng
• Email: zengny1@i.smu.edu.cn
• Phone: 13928801657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.