Actively Recruiting

Age: 18Years +
All Genders
NCT06447870

Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-06-07

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In recent years, biologic agents such as infliximab, vedolizumab, and ustekinumab have demonstrated tremendous potential in the treatment of inflammatory bowel disease (IBD), altering the traditional treatment paradigm for IBD. Despite their significant efficacy, there remains a subset of patients who do not respond to biologic agents, necessitating research into the response mechanisms of biologic therapy to explore more precise treatment strategies. Preliminary work by the principal investigator has identified multiple potential responder cell subtypes to biologic agents, which may be influenced by the gut and oral microbiota. Therefore, this project proposes to investigate the mechanisms of response to biologic agents, aiming to explore more precise treatment strategies, through the integration of single-cell transcriptomics, 16S rRNA, and other multi-omics technologies on tissue samples, feces, saliva, peripheral blood, etc., from IBD patients before and after treatment. This will involve integrating bioinformatics analysis and in vitro/in vivo functional validation to elucidate the roles of treatment-responsive cell subtypes and gut and oral microbiota in the inflammatory microenvironment of the intestine, with the aim of uncovering the mechanisms of biologic agent therapy and providing new clues for the development of next-generation drug targets.

CONDITIONS

Official Title

Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines
  • Have not previously received any biologic therapy or require treatment with infliximab, adalimumab, vedolizumab, or ustekinumab as judged by their physician after 3 months of medication
Not Eligible

You will not qualify if you...

  • Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab or have contraindications to these treatments
  • Current use of antibiotics or contact with probiotics/antibiotics in the past month
  • Presence of active autoimmune diseases, active tumors, or severe oral diseases
  • Patients with other diseases not related to inflammatory bowel disease that could affect treatment efficacy
  • Pregnant or lactating women
  • Those judged unsuitable for participation by the investigator

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

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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Research Team

X

Xinmei Zhao

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

2

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