Actively Recruiting

Age: 45Years +
All Genders
Healthy Volunteers
NCT06539832

Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Led by Zhujiang Hospital · Updated on 2024-09-19

300

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intestinal Flora and Immunity in Monoclonal Gammopathy Patients

Who Can Participate

Age: 45Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 years and older
  • Monoclonal gammaglobulin negative by MALDI-TOF MS screening
  • No symptoms of infection and normal infection markers (whole blood hs-CRP, serum IL-6, PCT)
  • Sufficient remaining whole blood, plasma, and fecal samples available with relevant case information
Not Eligible

You will not qualify if you...

  • Previous diagnosis of intestinal tumor, irritable bowel syndrome, or inflammatory bowel disease
  • Antibiotic therapy within the last month
  • Severe systemic diseases including malignant tumors
  • Insufficient sample volume or sample failure such as severe hemolysis, lipemia, or jaundice

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China, 510280

Actively Recruiting

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Research Team

N

Nianyi Zeng

CONTACT

H

Hongwei Zhou, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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