Multi-omics to Predict Responses to Biologics in IBD (MORE)

Sun Yat-sen University

Status: Enrolling

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Drug: Biologics

Study type: Observational

Funder types: Other

Identifiers

NCT05542459

2022ZSLYEC-136

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,050 participants in 3 patient groups

Non-IBD control group

Description:

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

CD group

Description:

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

Treatment:

Drug: Biologics

UC group

Description:

A group in which patients are diagnosed as ulcerative colitis

Treatment:

Drug: Biologics