RecruitingNCT06165029

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

Intestinal Ultrasound Combined With Visceral Adipose Tissue Predicts Anti-TNF-α Efficacy in Patients With Inflammatory Bowel Disease: a Prospective Study


Sponsor

The Third Xiangya Hospital of Central South University

Enrollment

50 participants

Start Date

Nov 22, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study is testing whether combining intestinal ultrasound (IUS) — a non-invasive imaging test — with a measure of visceral abdominal fat (VAT) can predict how well anti-TNF-alpha drugs (a common class of biologics) will work in patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Up to one-third of patients who initially respond to these drugs lose their response within a year, so better predictors of treatment success are urgently needed. Adults aged 18 to 80 with newly diagnosed or relapsed active IBD who are starting anti-TNF-alpha therapy and have not had abdominal surgery are eligible — those with contraindications to anti-TNF therapy or allergy to ultrasound contrast agent are excluded. Participation involves intestinal ultrasound and abdominal fat measurements at baseline and follow-up visits to track treatment response over time, without any change to standard medical care. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

the Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT06165029


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