Analyzing gut microbiota in patients with monoclonal gammopathy
Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression
This study is trying to see how the gut bacteria of people with monoclonal gammopathy differ from those without the condition to help find new ways to diagnose and treat it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2990 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06690593 on ClinicalTrials.gov |
What this trial studies
This observational case-control study aims to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). It will collect blood and stool samples from MGUS patients, non-MGUS patients with similar diseases, and healthy controls, totaling nearly 3,000 samples. The study will utilize multi-omics detection methods, including microbiomics and biochemical immunology, to identify abnormal features of the gut microbiome in MGUS patients. The findings may lead to new biomarkers and insights into the diagnosis and treatment strategies for MGUS.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 years or older who have been screened negative for monoclonal protein and do not have significant diseases.
Not a fit: Patients with a history of intestinal tumors, inflammatory bowel disease, or those who have received antibiotics in the past month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new biomarkers for diagnosing and evaluating the prognosis of MGUS.
How similar studies have performed: Other studies have shown promise in analyzing gut microbiota in relation to various diseases, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
(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.
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.