NCT04946448 COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
| NCT ID | NCT04946448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2021-09-14 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2021-09-14 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.
Eligibility Criteria
Inclusion Criteria: * Adult patients (18-80 years) * active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis), * patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) \> 8, * faecal calprotectin above 250 µg/g. Exclusion Criteria: * Abcess, * Bowel resection within 6 months before enrolment, * Ostomy, * Short-bowel syndrome, * Clinically significant stricture that could require surgery, * Pregnant, * Lactating woman or desire to become pregnant during the study, * Unwilling or unable to follow the study diet.
Contact & Investigator
João PG Sabino, MD PhD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT04946448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04946448 currently recruiting?
Yes, NCT04946448 is actively recruiting participants. Contact the research team at joao.sabino@uzleuven.be for enrollment information.
Where is the NCT04946448 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT04946448 clinical trial?
NCT04946448 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is João PG Sabino, MD PhD at UZ Leuven. The trial plans to enroll 144 participants.