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Taking people in ChinaNo phase

Studies how hard-to-treat Crohn's disease affects patients in China

Observes adults with Crohn's disease that does not respond well to treatment.

Key facts

Who runs it
Xiang Gao
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Status
Recruiting
People taking part
1,400 people, planned
Started
1 Nov 2025
Expected to end
30 Nov 2027
Type of study
Observational
Record updated
23 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a confirmed diagnosis of Crohn's disease. It follows them over time to see how treatment works.

Age
18 to 65 years
Sex
All sexes can join
Disease stage
Confirmed Crohn's disease. The record does not name a stage or severity for joining.

Main reasons for not taking part

  • Unclear Crohn's disease diagnosis
  • Seriously missing baseline clinical data
  • Currently in a clinical trial or taking experimental drugs
  • Other reasons biologics or small molecule drugs cannot be used, such as active infection or pregnancy
  • Short bowel syndrome, or a small bowel stoma or colostomy

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • The diagnosis of Crohn's disease was confirmed
  • Patients aged 18-65
  • Informed consent was obtained voluntarily

Who cannot take part

  • 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
  • The diagnosis of CD was unclear
  • The clinical baseline data were missing seriously
  • Patients with a small bowel or colostomy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in China

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Xiang GaoTaking people

About the trial

What the trial wants to find out

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 different mechanisms. Our previous retrospective data suggested that compared with foreign DTT-CD patients, there was no significant difference in the proportion of patients with advanced treatment failure due to more than two different mechanisms, but the proportion of patients with recurrence after two intestinal resection and complex anal fistula was increased. Therefore, this project aims to determine the current prevalence and epidemiological status of DTT-CD in China; To clarify the difference in efficacy and prognosis between DTT-CD patients and non DTT-CD patients using advanced treatment (including biological agents and small molecule drugs); Objective to evaluate the incidence and risk factors of non DTT-CD patients progressing to DTT-CD within 1 year. To further verify whether the domestic DTT-CD population is significantly different from the foreign population, and provide theoretical support for the selection of subsequent treatment options.

The group in the trial

  • Total study population

    The total study population included all CD patients who visited the Sixth Affiliated Hospital of Sun Yat sen University during the specified time period (November 2025 to January 2026), including newly diagnosed and previously diagnosed patients

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study
Plain-language title
Studies how hard-to-treat Crohn's disease affects patients in ChinaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07364734, who can take part
Record updated
23 January 2026