Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
Observational · No treatment assigned · 1 site · The Third Xiangya Hospital of Central South University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD), Vedolizumab and Intestinal Ultrasound. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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,;
Plus 2 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2025-06-01.
- Main results expected around 2027-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Bowel wall thickess(BWT) (follow-up time of about 52 weeks)
In the researchers’ words
Crohn's disease(CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood,characterized by transmural inflammation , can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. In recent years, the incidence of CD has increased rapidly, causing a heavy social and economic burden.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD); Vedolizumab; Intestinal Ultrasound; Predictor |
| Lead sponsor | The Third Xiangya Hospital of Central South University |
| Collaborators | The First Affiliated Hospital of University of South China; The First People's Hospital of Changde City; The Central Hospital of Shaoyang City; First People's Hospital of Chenzhou |
| Enrollment | 60 (estimated) |
| Start date | 2025-06-01 |
| Primary completion (est.) | 2027-06-30 |
| First posted | 2025-07-30 |
| Last updated | 2025-07-30 |
| Official title | Value of Intestinal Ultrasound in Predicting Vedolizumab Response and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study |
| ClinicalTrials.gov ID | NCT07093294 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha, Hunan | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.