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Multi-omics to Predict Responses to Biologics in IBD

Multi-omics to Predict Responses to Biologics in IBD

Non Recruiting
18-70 years
All
Phase N/A

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Overview

Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).

Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.

In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.

Eligibility

Inclusion Criteria:

  1. For patients with IBD:
    • Patients with IBD treated with approved biologics
    • Age 18 or over
    • Written informed consent obtained from patient for participation
  2. For non-IBD healthy volunteers:
    • Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study
    • Age 18 or over
    • Written informed consent obtained from patient for participation

Exclusion Criteria:

  • Unable to obtain written informed consent
  • Patient is, in the opinion of the investigator, not suitable to participate in the study

Study details
    Crohn Disease
    Ulcerative Colitis

NCT05542459

Sixth Affiliated Hospital, Sun Yat-sen University

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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