Exploring why some patients with inflammatory bowel disease don't respond to biologic treatments
Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology
This study is trying to find out why some people with inflammatory bowel disease don’t respond to biologic treatments by looking at their cells and gut bacteria before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | infliximab, adalimumab, vedolizumab, ustekinumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06447870 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the mechanisms behind treatment non-response in patients with inflammatory bowel disease (IBD) who are prescribed biologic therapies. By utilizing multi-omics technologies, including single-cell transcriptomics and microbiota analysis, the study aims to identify specific responder cell subtypes and their interactions with gut and oral microbiota. Tissue samples, feces, saliva, and blood will be collected from IBD patients before and after treatment to better understand the factors influencing treatment efficacy. The ultimate goal is to develop more precise treatment strategies for IBD patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with inflammatory bowel disease who have not previously received biologic therapy.
Not a fit: Patients who refuse biologic treatment or have contraindications, as well as those with active autoimmune diseases or severe oral conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective and personalized treatment strategies for patients with inflammatory bowel disease.
How similar studies have performed: While there have been studies exploring treatment responses in IBD, this specific multi-omics approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication. Exclusion Criteria: * Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
Where this trial is running
Guangzhou, Guangdong
- NanFang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xinmei Zhao
- Email: xmzhao914@163.com
- Phone: 13268270713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.