Crohn'sUCNot yet recruiting
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Observational · No treatment assigned · Sites not listed yet · First Affiliated Hospital, Sun Yat-Sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases (IBD), Crohn Disease and Colitis, Ulcerative. 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 16 and older
- Any sex
Some of the main requirements, copied from the record:
- Age 16 years or older. Established diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified based on clinical, endoscopic, imaging, and/or histopathological assessment.
- Received longitudinal care at a participating study centre during the study period.
- Sufficient patient identifiers and clinical dates to permit longitudinal record linkage and removal of duplicate records.
- For the advanced-therapy longitudinal cohort, a verifiable advanced-therapy exposure and treatment start date.
- Patients meeting any prespecified DTT-IBD domain may enter the DTT registry irrespective of whether DTT status is driven by medical treatment failure, postoperative disease, complex perianal disease, pouch-related disease, or other…
- Prospective participants provide informed consent where required by the ethics committee; retrospective data may be included under an approved waiver of informed consent.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 2000 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-11-01 (planned).
- Main results expected around 2032-10-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- IBD Longitudinal Registry Cohort
Main thing being measured
- Prevalence of Difficult-to-Treat Inflammatory Bowel Disease (At index assessment)
- Cumulative Incidence of Newly Developed Difficult-to-Treat Inflammatory Bowel Disease (From cohort entry through 36 months)
In the researchers’ words
Difficult-to-treat inflammatory bowel disease (DTT-IBD) represents a heterogeneous group of patients with treatment-refractory, structurally complicated, postoperative, perianal, pouch-related, or psychosocially complex disease. This multicentre ambidirectional observational cohort will establish a longitudinal registry of adults with inflammatory bowel disease and systematically identify patients meeting…
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
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 | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases (IBD); Crohn Disease; Colitis, Ulcerative |
| Lead sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Collaborators | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 2000 (estimated) |
| Start date | 2026-11-01 |
| Primary completion (est.) | 2032-10-31 |
| First posted | 2026-10-16 |
| Last updated | 2026-10-16 |
| Official title | A Multicentre Observational Cohort Study of Difficult-to-Treat Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07877649 |
Interventions
- Routine IBD Management and Advanced-Therapy Exposure (Other)
Treatment exposure, optimization, switching, discontinuation, surgery, monitoring, and multidisciplinary management occurring as part of routine clinical care. No exposure is assigned by the study protocol.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age 16 years or older. Established diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified based on clinical, endoscopic, imaging, and/or histopathological assessment. Received longitudinal care at a participating study centre during the study period. Sufficient patient identifiers and clinical dates to permit longitudinal record linkage and removal of duplicate records. For the advanced-therapy longitudinal cohort, a verifiable advanced-therapy exposure and treatment start date. Patients meeting any prespecified DTT-IBD domain may enter the DTT registry irrespective of whether DTT status is driven by medical treatment failure, postoperative disease, complex perianal disease, pouch-related disease, or other prespecified qualifying domains. Prospective participants provide informed consent where required by the ethics committee; retrospective data may be included under an approved waiver of informed consent. Exclusion Criteria: * Inflammatory bowel disease diagnosis cannot be adequately confirmed. Age younger than 18 years at cohort eligibility. Records cannot be reliably linked to a unique participant or contain insufficient information to establish the relevant longitudinal timeline. Prospective participant declines participation where informed consent is required.
Locations (0)
No sites listed yet. The official record has contact information.
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.