Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gut Microbiota | — | UNRESOLVED | — |
| Infections | — | UNRESOLVED | — |
| MGUS | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| M-Protein | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Monoclonal gammopathy patients without concurrent infection
- description
- (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions.
- label
- Monoclonal gammopathy patients with concurrent infection
- description
- (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. Presence of infection symptoms, with abnormal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions.
- label
- Healthy control group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available