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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
the Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Li Tian
f3tianli@outlook.com
0731-13574843423
Backup
Mingmei Ye
17320071569@163.com
0731-19376955445
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 50
Sponsors
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov