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NCT03574948
NCT03574948
Who may be able to join
Who might be able to join this trial:
- You are between 18 and 60 years old (inclusive)
- You have been diagnosed with Crohn's disease or ulcerative colitis
- Your doctor believes you are able to understand and follow the study requirements
- Your inflammatory bowel disease has been in remission (not actively flaring) for the past 3 months, as assessed by your doctor
- Your disease is confirmed to be in remission at the start of the study based on specific scoring systems (confirm with trial site)
- You rate your fatigue as 5 or higher on a scale of 0 to 10
- You have been taking biological therapies and/or immune-suppressing medications for at least 6 months, with no change in dose for the past 3 months
- Your blood and stool test results at the start of the study confirm your disease is in remission (low inflammation markers) (confirm with trial site)
Who may not be able to join:
- You have a diagnosed clinical depression
- You are currently taking antidepressants or antipsychotic medications
- You have any diagnosed psychiatric condition
- You have significant other health conditions such as heart disease, lung disease, or cancer
- You have diagnosed anaemia or low levels of vitamin B12 or folic acid, based on recent blood tests
- You have a diagnosed underactive thyroid, confirmed by a recent blood test
- You have had an infection in the 2 weeks before joining the study
- Your IBD medications (biologicals or immunosuppressants) have changed in the 12 weeks before joining the study
- You have taken steroid tablets (oral corticosteroids) in the 8 weeks before joining the study
- You are currently pregnant or breastfeeding
- You have a history of certain blood cancers or any cancer other than a specific type of skin cancer
- You have had surgery in the 12 weeks before the screening visit
- You have a history of significant drug misuse or alcohol misuse in the past year
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.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
University Hospital, Ghent
Registry
clinicaltrials_gov
Start date
6 December 2018
Est. completion
23 February 2021
Where this trial is recruiting
🇧🇪 Belgium
Primary endpoints
Change in Visual Analog Scale (VAS) after intervention
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.