Using intestinal ultrasound to predict vedolizumab response and transmural healing in early Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective observational study enrolling adults with early Crohn's disease who are biologic- and advanced-therapy–naïve. Participants will receive baseline endoscopy and intestinal ultrasound (IUS) and begin vedolizumab within one month of those assessments, with follow-up imaging and clinical monitoring to track response and healing. The study will correlate baseline and longitudinal IUS findings with clinical outcomes and mucosal/transmural healing. Results aim to identify ultrasound features that predict which patients benefit most from vedolizumab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years;
* Early CD patients (disease duration ≤18 months, biologic-naïve and treatment-naïve for advanced therapies, without complications such as fistulas or strictures)
* Vedolizumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,;
* No history of intestinal surgery;
* Clearly understand, voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

* Contraindications to vedolizumab: 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.

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Tian Li
• Email: f3tianli@outlook.com
• Phone: 0731-13574843423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.