Gut Microbiota Profiling in Patients With Monoclonal Gammopathy: Implications for Disease Pathogenesis and Progression

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
View:

• Age 45 years or older;

• Negative screening for monoclonal protein by MALDI-TOF MS;

• No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study;

• Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided.

Locations
Other Locations
China
Zhujiang Hospital of Southern Medical University
RECRUITING
Guanzhou
Contact Information
Primary
Nianyi Zeng
zengny1@i.smu.edu.cn
13928801657
Backup
Hongwei Zhou, Professor
Time Frame
Start Date: 2024-12-26
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 2990
Treatments
Monoclonal gammopathy patients
(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.
Non-monoclonal gammopathy patients
(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.
Healthy control group
(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.
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov