Multi-omics to Predict Responses to Biologics in IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-IBD control group

A control group in which patients are not diagnosed as inflammatory bowel disease.

No interventions assigned to this group

CD group

A group in which patients are diagnosed as crohn's disease

Biologics

Intervention Type DRUG

Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

UC group

A group in which patients are diagnosed as ulcerative colitis

Biologics

Intervention Type DRUG

Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

Interventions

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Biologics

Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

Intervention Type DRUG

Eligibility Criteria

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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