Intestinal ultrasound predicts guselkumab response in moderate-to-severe 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 prospective observational study enrolling adults with newly diagnosed or relapsed moderate-to-severe Crohn's disease who are starting guselkumab. Participants will have baseline intestinal ultrasound (IUS) and endoscopy within one month before beginning guselkumab, and imaging features will be recorded. Clinical and endoscopic outcomes after guselkumab treatment will be tracked and compared to baseline IUS findings to identify predictive ultrasound markers. The goal is to determine whether noninvasive IUS features correlate with subsequent treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥ 18 years and ≤ 80 years;

* Patients with newly diagnosed or relapsed moderate to severe Crohn's disease;
* Guselkumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound;
* No history of abdominal surgery;
* Clearly understand, voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

* Contraindications to Guselkumab: allergy, active tuberculosis or other active infections, and comorbidities such as severe liver dysfunction;
* 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: Li Tian
• 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.