Measuring how common and how treatment-resistant difficult-to-treat Crohn's disease is in China.
Official title: Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT07364734 · Data updated 2026-11-12
This project will measure how common difficult-to-treat Crohn's disease is in adults in China and see how their treatment responses and prognosis compare to other Crohn's patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1400 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT07364734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with a confirmed diagnosis of Crohn's disease who can give informed consent and have adequate baseline clinical data are eligible.
✕Probably not a fit
Patients with unclear Crohn's diagnoses, severely missing baseline data, current participation in experimental drug trials, short bowel syndrome, or an ostomy are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, hospital-based study that uses the IOIBD 2023 definition to identify adults with difficult-to-treat Crohn's disease (DTT-CD) and collects demographic, clinical, treatment history, surgical history, and outcome data. Investigators will estimate the prevalence of DTT-CD among eligible Crohn's patients at the recruiting center and compare rates of treatment failure, recurrence, surgeries, and complex anal fistula between DTT-CD and non-DTT-CD groups. Key exclusions include unclear diagnoses, seriously missing baseline data, current enrollment in experimental drug trials, contraindications to biologics or small molecules, short bowel syndrome, and ostomy. Standard epidemiological analyses and group comparisons will be used to describe differences in efficacy and prognosis.
Why it matters
Potential benefit: If successful, the project could clarify how common DTT-CD is in China and help clinicians prioritize monitoring and treatment strategies for higher-risk patients.
How similar studies have gone: International epidemiological work has reported DTT-CD in about 24.8% of Crohn's patients and some retrospective analyses have noted differing patterns, but prospective or large-scale Chinese data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xiang Gao
- Email: gxiang@mail.sysu.edu.cn
- Phone: +86-020-38663423
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission
This study tests whether microencapsulated sodium propionate can favorably alter the gut microbiota and inflammation in adults with Crohn’s disease, compared with sodium butyrate.
-
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
This study tests whether risankizumab can help people with Crohn’s disease who have draining perianal fistulas not responding to other treatments.
-
Intestinal ultrasound-guided management for inflammatory bowel disease
This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.
-
Laser-based sizing of GI lesions during endoscopies
This study tests whether the AccuMeasure laser tool gives more accurate and reliable lesion size measurements during colonoscopies for adults with colon polyps or Crohn’s disease than traditional endoscopic estimates.
-
A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis
A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.
-
Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies
This study tests whether staining for Claudin-2 in intestinal biopsy samples can help identify active vs. inactive inflammation in people with ulcerative colitis or Crohn's disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.