NCT06539832Recruiting
Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 22 Jul 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 May 2026
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT06539832
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 May 2024 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Severe systemic diseases including malignant tumours;
- Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.