Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Observational · No treatment assigned · 1 site · Xiang Gao
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. 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 65
- Any sex
Some of the main requirements, copied from the record:
- The diagnosis of Crohn's disease was confirmed;
- Patients aged 18-65;
- Informed consent was obtained voluntarily.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1400 participants are expected to take part.
- Start date: 2025-11-01.
- Main results expected around 2027-11-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- steroid-free remission (From the beginning of enrollment to 1 year)
In the researchers’ words
Difficult to treat Crohn's disease (DTT-CD) was defined by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) in 2023, which refers to CD patients with poor response to drug treatment and poor prognosis. Foreign epidemiological studies have shown that DTT-CD accounts for 24.8% of all CD patients, and most of them are patients with advanced treatment failure according to more than two…
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 |
| Lead sponsor | Xiang Gao |
| Enrollment | 1400 (estimated) |
| Start date | 2025-11-01 |
| Primary completion (est.) | 2027-11-01 |
| First posted | 2026-01-23 |
| Last updated | 2026-01-23 |
| Official title | Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study |
| ClinicalTrials.gov ID | NCT07364734 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * The diagnosis of Crohn's disease was confirmed; * Patients aged 18-65; * Informed consent was obtained voluntarily. Exclusion Criteria: * The diagnosis of CD was unclear; * The clinical baseline data were missing seriously; * Patients currently enrolled in clinical trials or receiving experimental drugs; * Other contraindications to biologics or small molecule drugs (including active infection, pregnancy, etc.); * Patients with short bowel syndrome; * Patients with a small bowel or colostomy.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | 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.