Crohn's Disease and Colitis Trial, Recruiting NCT05387031 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05387031
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with moderate to severe Crohn's disease
  • You have had symptoms of a blocked or narrowed bowel (such as pain, bloating, or difficulty with digestion) within the last 8 weeks
  • A scan or camera procedure has found one or more narrowed sections in your bowel (called strictures)
  • Your narrowed bowel section was identified by a special CT scan showing the bowel is significantly narrowed, the bowel wall is thickened, and there is a build-up of pressure before the narrowing (confirm with trial site for exact measurements)
  • OR your narrowed bowel section was found during a camera (endoscopy) procedure, where the passage was very tight or the camera could not pass through at all

Who may not be able to join:

  • Your doctor believes you need urgent surgery or an urgent camera procedure within the next 2 months
  • You have signs of a hole or rupture in your bowel, a pocket of infection (abscess), an abnormal tunnel between organs (fistula), or bowel tissue stuck together (adhesions)
  • Your bowel blockage was caused by a previous surgery, an abscess inside the abdomen, or a single isolated narrowing of a specific type (confirm with trial site)
  • You have had a treatment for your bowel narrowing in the past 6 months, such as balloon stretching, surgery to widen the bowel, or similar procedures
  • You have been unable to eat even with the help of liquid nutritional feeds for more than 2 months
  • You have used a medication called ustekinumab or a similar type of drug (IL-23 blocker) in the past 12 months
  • You cannot have the CT scan required, for example due to an allergy to the dye used in scans
  • You have certain health conditions that may make biological medicines (a type of drug used in this trial) unsafe for you, such as tuberculosis, heart attack history, heart failure, or certain nervous system diseases
  • You are currently being treated for a solid tumour, lymphoma, or melanoma with chemotherapy or radiation therapy
  • You have short bowel syndrome, a colostomy bag, or a tumour in your bowel or rectum
  • You have active bleeding in your digestive system, severe diarrhoea, uncontrollable vomiting, shock, or severe problems absorbing nutrients
  • You have serious liver or kidney problems
  • You currently have an active bacterial or viral infection
  • You are pregnant or breastfeeding
  • You have very unstable health, rapidly worsening illness, or a condition that is considered life-threatening during the study period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Yan Chen, MD., Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine

Phone: +86-571-87783777

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 August 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants with treatment success at week 52

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov