Clinical trial · Observational
Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy
Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
- 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 is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intestinal Flora | — | UNRESOLVED | — |
| Monoclonal Gammopathy of Undetermined Significance (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
- description
- (I) Inclusion Criteria: 1. Age 45 years or older. 2. Positive screening for monoclonal protein by MALDI-TOF MS. 3. Meeting the International Classification of Diseases, 11th Revision (ICD-11) criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
- label
- Non-monoclonal gammopathy patients
- description
- (I) Inclusion Criteria: 1. Age 45 years or older. 2. Negative screening for monoclonal protein by MALDI-TOF MS. 3. Patients meeting ICD-11 criteria for one of the following disease types:Infectious diseases，Tumors，Blood or hematopoietic organ diseases，Immune system diseases，Endocrine, nutritional, or metabolic diseases，Nervous system diseases，Circulatory system diseases，Respiratory system diseases，Digestive system diseases，Musculoskeletal or connective tissue diseases，Urinary and reproductive system diseases. 4. Sufficient whole blood, plasma, serum, and stool samples available, with relevant case data provided. (II) Exclusion Criteria: 1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization. 2. Antibiotic treatment in the past month. 3. Insufficient sample volume, or severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
(I) Inclusion Criteria: 1. Age 45 years or older; 2. Negative screening for monoclonal protein by MALDI-TOF MS; 3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study; 4. Sufficient whole blood, plasma, serum, 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. Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
References
Publications (0)
Data not yet available