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Inflammatory Bowel DiseasesNCT06165029

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

An observational study of Inflammatory Bowel Diseases and Intestinal Ultrasound, run by The Third Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
50 participants
Where
1 siteChina
Study dates
22 Nov 2023to 30 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • the Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Li Tian, MD, 13574843423, tianlixy3@csu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

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). In recent years, the incidence of IBD in newly industrialized countries is rapidly increasing and is becoming younger. 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.

In recent years, many studies have begun to focus on the role of intestinal ultrasound (IUS) in the diagnosis of disease, activity, outcome monitoring, and prediction in patients with IBD. As a noninvasive, reproducible, convenient, and inexpensive test, the ability of intestinal ultrasound to be used as a point-of-care ultrasound may dramatically change the frequency of assessing response to therapy and speed up the clinical decision-making process, and guidelines recommend it as a routine test in patients with IBD. Large multicenter studies have shown that most ultrasound markers return to normal within 12 weeks of treatment initiation, and in particular, normalization of bowel thickness (BWT) is highly correlated with clinical response at 12 weeks. Other subsequent studies have also shown that IUS predicts clinical and endoscopic outcomes in patients with IBD, both in UC and CD, but with limitations, and the predictive efficacy of the further-developed bowel ultrasound score is not sufficient for the clinical need.

Visceral adipose tissue (VAT) refers to the white adipose tissue surrounding the viscera, which is mainly divided into omental adipose tissue, mesenteric adipose tissue (MAT), retroperitoneal fat, perigonadal fat, and peripicardial fat. The role of visceral fat in inflammatory diseases has been gradually emphasized, and it has been found that visceral fat has a special secretion function of inflammatory mediators, which can produce a variety of inflammatory factors, such as TNF-α, interleukin- 6 (IL-6), etc., and these factors play an important role in the inflammatory process. A retrospective study analyzed the relationship between VAT levels and infliximab-induced mucosal healing in 97 CD patients, and found that increased VAT levels were independently associated with attenuated mucosal healing. Gu et al. investigated the effect of visceral fat on the response to treatment and the risk of subsequent surgery in patients with IBD who were treated with anti-TNF-α therapy, and found that visceral fat could also serve as a potential predictor of the efficacy of anti-TNF-α therapy.

Currently, there are no relevant studies at home or abroad on the combination of IUS with 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.

Medical subject headings
Inflammatory Bowel Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel wall thickness (BWT)

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

    Measured: follow-up time of about 54 weeks

  2. 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)

    Measured: follow-up time of about 54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start22 Nov 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165029
Sponsor's protocol ID
fu3tianli2
Status last verified
Aug 2024
First submitted
20 Nov 2023
Last updated
27 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Intestinal Ultrasound, run by The Third Xiangya Hospital of Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Tian (0731-13574843423, f3tianli@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel wall thickness (BWT) (time frame: follow-up time of about 54 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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