Clinical trial Recruiting at 1 site Observational Ages 18 to 65

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.

More Crohn Disease trials

Quick facts

Study typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment1400 (estimated)
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedNovember 1, 2025
Main results expectedNovember 1, 2027
Study endsNovember 30, 2027
Registry record updatedJanuary 23, 2026
Trial IDNCT07364734 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.