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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Inflammatory Bowel Diseases; Diet, Healthy; Crohn Disease

Treatments: Other: FIT diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04946448

S64746

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

FIT group

Experimental group

Description:

Patients treated with biological treatment and the FIT diet

Treatment:

Other: FIT diet

Control group

No Intervention group

Description:

Patients treated with biological treatment and the standard diet