Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT06860009 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT06860009
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

  • The person joining (or their legal representative) must have given written agreement to take part before any screening tests are done.
  • Adults aged between 18 and 70 years old, of any gender.
  • People who have been diagnosed with ulcerative colitis, Crohn's disease, or inflammatory bowel disease that has not been clearly classified as either type, based on imaging, camera examination of the gut, and/or tissue samples.
  • People whose bowel disease has been present for more than one year.
  • People who score below 30 on the FACIT Fatigue scale, which is a standard questionnaire that measures tiredness and fatigue (confirm with trial site).
  • People who own and use a smartphone.
  • People who are able to commit to making daily changes to their lifestyle or behaviour.
  • People who are fluent in Dutch.

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 started a new bowel disease medication (such as steroids, mesalamine, thiopurines, methotrexate, biologics, or small molecule drugs) in the three months before screening.
  • People who show signs of currently active bowel disease based on specific blood or stool test results at screening (confirm with trial site).
  • People who are currently taking part in another clinical trial that involves an investigational medicine or medical device.
  • People who have a planned surgery scheduled at the time of screening.
  • People who have low levels of iron, vitamin D, vitamin B12, or folic acid, or who show signs of malnutrition (such as significant recent weight loss, a very low body weight index, or low protein levels in the blood) at screening (confirm with trial site).
  • People who have a thyroid condition or abnormally low phosphate levels in the blood at the time of screening.
  • People who have a physical injury at the time of screening, as assessed by the researcher.
  • People who report having sleep problems or episodes where breathing stops during sleep (such as sleep apnoea) at the time of screening.
  • People with a body mass index (BMI) above 30 at the time of screening, which is a measure of body weight relative to height.
  • People who have a current or past diagnosis of a serious mental health condition, including ongoing major depression, schizophrenia, bipolar disorder, or ongoing substance abuse.
  • People who started a new mental health medication, or had their existing mental health medication dose changed, in the three months before screening.

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.

GP referral letter

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Trial details

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

Primary endpoints

FACIT fatigue scale

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