Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study

Launched by THE THIRD XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a simple, painless test called intestinal ultrasound (which uses sound waves to take pictures of the intestines) can predict how well a medicine called vedolizumab works in people with early Crohn’s disease. Crohn’s disease is a long-term condition that causes inflammation deep in the walls of the intestines and can lead to serious problems like blockages or infections. Vedolizumab is a newer treatment that helps reduce this inflammation. The study aims to see if ultrasound can help doctors know early on if this medicine is working and if the intestines are healing properly.

Adults between 18 and 80 years old who have recently been diagnosed with Crohn’s disease (within the last 18 months) and have not yet tried treatments like vedolizumab are eligible to join. Participants will have an ultrasound and an endoscopy (a test where a small camera looks inside the intestines) before starting the medicine. The study will then track their progress to see if the ultrasound helps predict treatment success. This study is important because it could offer a quick, easy way to guide treatment plans and improve care for people with early Crohn’s disease.

Gender

ALL

Eligibility criteria

• 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.