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

NCT06165029 | Recruiting

• 1 other identifier: fu3tianli2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Intestinal Ultrasound; Visceral Adipose Tissue; TNF-α; Predictors

Outcome Measures

Primary Outcomes (2)

• Bowel wall thickness (BWT)

  BWT is measured by intestinal ultrasound. BWT≤3mm means that CD is in quiescent, \>3mm means CD is active

  follow-up time of about 54 weeks

• visceral adipose tissue (VAT)

  VAT was obtained from a computed tomography (CT) or magnetic resonance imaging (MRI) scan and measured at the level of the third lumbar vertebra. APP:NIH ImageJ 1.47 (Bathesda, Maryland, America)

  follow-up time of about 54 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the Third Xiangya Hospital of Central South University, patients with newly diagnosed or relapsed IBD treated with anti-TNF-α will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

the Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Li Tian

  The Third Xiangya Hospital of Central South University

  STUDY CHAIR

Central Study Contacts

Li Tian

CONTACT

0731-13574843423; f3tianli@outlook.com

Mingmei Ye

CONTACT

0731-19376955445; 17320071569@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Li Tian,MD[fu3tianli]

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 11, 2023
• Study Start: November 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)