NCT06539832 Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
| NCT ID | NCT06539832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-05-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Hongwei Zhou, Professor
STUDY CHAIR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT06539832 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06539832 currently recruiting?
Yes, NCT06539832 is actively recruiting participants. Contact the research team at zengny1@i.smu.edu.cn for enrollment information.
Where is the NCT06539832 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT06539832 clinical trial?
NCT06539832 is sponsored by Zhujiang Hospital. The principal investigator is Hongwei Zhou, Professor at Southern Medical University, China. The trial plans to enroll 300 participants.