COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

Universitaire Ziekenhuizen KU Leuven1 site in 1 country144 target enrollmentSeptember 14, 2021

ConditionsCrohn Disease Inflammatory Bowel Diseases Diet, Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Crohn Disease
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 144
Locations: 1
Primary Endpoint: Steroid-free clinical and biochemical remission
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

September 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Responsible Party

Sponsor

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

•Bowel resection within 6 months before enrolment,
•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.

Outcomes

Primary Outcomes

Steroid-free clinical and biochemical remission

Time Frame: Month 6

Normalization of faecal calprotectin (\< 250 µg/g) and steroid-free clinical remission, defined as patient PRO2 ≤ 8 (average daily stool frequency ≤ 1.5 AND average daily abdominal pain score ≤ 1), at month 6.