Investigating gut microbiota and immune function in monoclonal gammopathy patients
Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
This study looks at the gut bacteria and immune system in patients with monoclonal gammopathy to see how they might be affected, especially in those with infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06539832 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older diagnosed with monoclonal gammopathy who do not exhibit symptoms of infection.
Not a fit: Patients with a history of intestinal tumors, inflammatory bowel disease, or those currently on antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how gut health influences immune function in monoclonal gammopathy patients, potentially leading to improved management strategies.
How similar studies have performed: While the specific approach of correlating gut microbiota with immune function in monoclonal gammopathy is novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guanzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Nianyi Zeng
- Email: zengny1@i.smu.edu.cn
- Phone: 13928801657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.