Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06165029

IUS Combined With VAT Predicts Anti-TNF-α Efficacy in Patients With IBD: a Prospective Study

Led by The Third Xiangya Hospital of Central South University · Updated on 2024-08-27

50

Participants Needed

1

Research Sites

70 weeks

Total Duration

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AI-Summary

What this Trial Is About

Inflammatory Bowel Disease (IBD) is a chronic recurrent nonspecific inflammatory disease of the intestinal tract that can involve multiple organs and systems, mainly including Crohn's disease (CD) and ulcerative colitis (UC). Recurrent disease episodes lead to high rates of disability and unemployment, resulting in a heavy social and economic burden. Currently, the main therapeutic agents for IBD include aminosalicylic acid preparations, glucocorticoids, immunosuppressive agents, and biologic agents, e.g. tumor necrosis factor-a (TNF-a) inhibitors, ustekinumab, etc., with TNF-a inhibitors being the most commonly used in IBD. The latest guidelines and expert consensus on the diagnosis and management of IBD clearly recommend the use of anti-TNF-a agents. However, not all patients are satisfied with the efficacy of anti-TNF-a agents, and studies have shown that up to 33.7% of responders to induction therapy experience secondary loss of response within a year of starting treatment. Patients remain at risk of poor efficacy or treatment failure with these drugs. Therefore, effective prediction of drug efficacy in patients with IBD is an urgent clinical problem, and the discovery of highly sensitive and specific assays that can identify patients most likely to benefit from treatment as well as those most likely to experience a loss of response is important for guiding clinical therapeutic strategies. Currently, there are no relevant studies at home or abroad on the combination of intestinal ultrasound (IUS) with visceral adipose tissue (VAT) to predict the response to anti-TNF-a therapy in IBD patients. Therefore, the investigators propose for the first time that IUS combined with VAT is used as a method to predict the efficacy of anti-TNF-a therapy in IBD patients and to further guide the development of individualized treatment plans.

CONDITIONS

Official Title

IUS Combined With VAT Predicts Anti-TNF-α Efficacy in Patients With IBD: a Prospective Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 18 years and 4 80 years
  • Patients with newly diagnosed or relapsed active inflammatory bowel disease
  • Planned anti-TNF-b1 monotherapy within 1 month after baseline endoscopy
  • No history of abdominal surgery
  • Able to understand the study, voluntarily agree to participate, and sign informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to anti-TNF-b1 therapy including allergy, active tuberculosis or other infections, moderate-to-severe heart failure (NYHA III/IV), nervous system demyelinating lesions, live vaccines within 3 months, pregnancy or breastfeeding
  • History of extensive colectomy or planned colectomy, history of colonic mucosal dysplasia
  • Hypersensitivity to SonoVue contrast media components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Actively Recruiting

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Research Team

L

Li Tian

CONTACT

M

Mingmei Ye

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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