Crohn's Disease and Colitis Trial, Recruiting NCT05791487 Sponsor: Wolfson Medical Center Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05791487
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 are willing and able to give informed consent to participate
  • You have been diagnosed with ulcerative colitis (UC) with mild to moderate active disease, based on a specific symptom score (SCCAI between 5 and 10)
  • You are between 17 and 65 years old (inclusive)
  • Your UC affects any extent of the colon, from the rectum only up to the full colon, as classified by your doctor
  • A camera examination (sigmoidoscopy) has confirmed active inflammation in your rectum or lower colon
  • You have been on a stable dose of certain medications — oral 5ASA for at least 8 weeks, or thiopurines, vedolizumab, ustekinumab, or tofacitinib for at least 12 weeks

Who may not be able to join:

  • You have severe colitis (SCCAI above 10), or you were hospitalised for a severe flare of colitis in the past 6 months
  • You have used steroid medications in the past 3 months
  • You are currently using, or have previously tried and stopped responding to, anti-TNF medications (a type of biologic therapy)
  • You follow a fully vegan diet (vegetarians may still be eligible)
  • You are pregnant
  • You are unable to take the medication budesonide due to having had serious side effects from it before
  • You have UC-related complications affecting other parts of the body, such as joint inflammation, spine inflammation, or eye inflammation
  • You have low albumin (a protein) levels in your blood (confirm with trial site)
  • You currently have a fever above 38°C
  • You have a current infection caused by a bacteria called Clostridioides difficile
  • You have kidney failure
  • You have liver disease, including hepatitis or a condition called Primary Sclerosing Cholangitis (PSC)
  • You currently have an active cancer (except for a common, slow-growing type of skin cancer called basal cell carcinoma)

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 28 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Wolfson Medical Center
Registry
ClinicalTrials.gov
Start date
1 December 2023
Est. completion
1 March 2026

Where this trial is recruiting

🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇨🇭 Switzerland

Primary endpoints

Steroid free remission

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: 28 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