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RECRUITINGNA

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

NCT04946448•Universitaire Ziekenhuizen KU Leuven

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University Hospital of Leuven

Leuven, Belgium

Key Dates

Start Date

September 14, 2021

Primary Completion Date

September 30, 2025

Completion Date

September 30, 2025

Last Updated

July 3, 2024

Enrollment

144

ESTIMATED participants

Conditions

Crohn DiseaseInflammatory Bowel DiseasesDiet, Healthy

Interventions

FIT diet

OTHER

Contacts

João PG Sabino, MD PhD

CONTACT

003216341770 joao.sabino@uzleuven.be

Isolde Aerden

CONTACT

isolde.aerden@uzleuven.be

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

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