Combining diet with biologic therapy for Crohn's disease
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
This study is testing if following a special diet along with biologic therapy can help adults with Crohn's disease feel better and reduce inflammation compared to a standard diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04946448 on ClinicalTrials.gov |
What this trial studies
This study is a randomized open-label trial that compares the FIT diet with a standard diet in adult patients suffering from Crohn's disease who are undergoing treatment with biologic therapy. The aim is to assess the effectiveness of dietary intervention in managing symptoms and inflammation associated with the disease. Participants will be monitored for changes in their condition based on specific clinical and patient-reported outcomes. The study focuses on patients with active inflammation of the terminal ileum and/or colon.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with active Crohn's disease and specific inflammatory markers.
Not a fit: Patients with recent bowel surgery, ostomies, or significant strictures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve symptom management and overall health outcomes for patients with Crohn's disease.
How similar studies have performed: Other studies have shown promising results with dietary interventions in inflammatory bowel diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven
- University Hospital of Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: João PG Sabino, MD PhD — UZ Leuven
- Study coordinator: João PG Sabino, MD PhD
- Email: joao.sabino@uzleuven.be
- Phone: 003216341770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.