Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT06338930 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT06338930
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People diagnosed with Crohn's disease, ulcerative colitis, or inflammatory bowel disease (IBD) that has not been clearly classified as either type.
  • People who have given voluntary written consent to participate (or whose legal representative has done so) before any screening takes place.
  • People who are at least 18 years old at the time of signing the consent form.
  • People who have access to the Mynexuzhealth app or website via smartphone or internet.
  • People who can fluently speak, read, and write in Dutch.
  • People who have been on a stable treatment with certain oral or injectable medications (such as mesalamine, thiopurines, methotrexate, injectable biologics, or oral small molecule drugs) for at least two years, or who have not been on any of these treatments for at least two years.
  • People who have access to the Mynexuzhealth (Plexus hospitals) or HiX (ZOL) patient portal.
  • People willing to do a stool sample test at home every three months using a specific app, or to visit their GP or a nearby hospital to have the stool test done every three months.
  • People willing to visit their GP or a nearby hospital for a blood test once a year.
  • People willing to visit their GP or a nearby hospital every three months for blood tests if they are being treated with thiopurines or methotrexate (to check liver function and blood cell counts).
  • The in-person clinic visit that occurs every two years can be carried out at UZ Leuven.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have received an intravenous (IV) biologic therapy or any form of corticosteroids (other than inhaled or skin-applied corticosteroids) in the past two years.
  • People whose IBD medications have been changed in the past two years (not counting changes to rectal therapies).
  • People who have had IBD-related surgery in the past two years.
  • People whom the IBD medical team considers to need more frequent monitoring than this trial allows — for example, due to past difficulties following treatment plans, a need for extra support, or other conditions such as primary sclerosing cholangitis or cancer.
  • People who are currently taking part in another clinical trial involving an investigational medication or medical device.
  • People who are pregnant at the time of screening (if pregnancy occurs during the study, the decision about continuing participation will be made on a case-by-case basis through discussion between the doctor and the patient).

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 14 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: Marc Ferrante, UZ Leuven

Phone: 016 342845

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
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
2 March 2027

Primary endpoints

Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years.

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: 14 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