Predicting the effectiveness of anti-TNF-α treatment in patients with inflammatory bowel disease
Intestinal Ultrasound Combined With Visceral Adipose Tissue Predicts Anti-TNF-α Efficacy in Patients With Inflammatory Bowel Disease: a Prospective Study
This study is testing if using ultrasound and measuring body fat can help doctors figure out which patients with inflammatory bowel disease will benefit most from a specific treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | ustekinumab, infliximab |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06165029 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of anti-TNF-α therapy in patients with inflammatory bowel disease (IBD) by using intestinal ultrasound and measuring visceral adipose tissue. It focuses on identifying predictors of treatment response to help clinicians determine which patients are most likely to benefit from this therapy. The study will include patients aged 18 to 80 years who have newly diagnosed or relapsed active IBD and are scheduled to start anti-TNF-α therapy. The goal is to improve treatment outcomes and reduce the burden of ineffective therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with newly diagnosed or relapsed active inflammatory bowel disease who are about to start anti-TNF-α therapy.
Not a fit: Patients with contraindications to anti-TNF-α therapy or those with a history of extensive colectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for patients with IBD, improving their response to anti-TNF-α therapy.
How similar studies have performed: While the approach of using predictors for treatment response is common, the specific combination of intestinal ultrasound and visceral adipose tissue measurement in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and ≤ 80 years; * Patients with newly diagnosed or relapsed active IBD; * Anti-TNF-α monotherapy is proposed to be applied within 1 month after baseline endoscopy; * No history of abdominal surgery; * Clearly understand, voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: * Contraindications to anti-TNF-α therapy: allergy, active tuberculosis or other active infections, moderate-to-severe heart failure (NYHA grade III/IV), demyelinating lesions of the nervous system, live vaccination within the last 3 months, pregnancy and lactation; * Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia; * Hypersensitivity to the components of SonoVue contrast media.
Where this trial is running
Changsha, Hunan
- the Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Tian
- Email: f3tianli@outlook.com
- Phone: 0731-13574843423
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.