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

Not Applicable

Recruiting

• Conditions: Crohn Disease; Diet, Healthy; Inflammatory Bowel Diseases
• Interventions: Other: FIT diet

• Registration Number: NCT04946448
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-30
• Study Start: 2021-09-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FIT group	FIT diet	Patients treated with biological treatment and the FIT diet

Primary Outcome Measures

Name	Time	Method
Steroid-free clinical and biochemical remission	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.

Secondary Outcome Measures

Name	Time	Method
Clinical remission	6 months and 1 year	PRO2≤8
Health-related quality of life	6 months and 1 year	30% or more improvement in overall IBD Disk score
Endoscopic improvement	1 year	drop in SES-CD with at least 50%
Steroid-free clinical remission	6 months and 1 year	PRO2≤8, no steroids
Endoscopic remission	1 year	SES-CD \<2
CRP improvement	6 months and 1 year	50% or more improvement in CRP or CRP \<5 mg/L
Fatigue	6 months and 1 year	30% or more improvement in IBD Disk energy score
Number of participants without nutritional deficiencies	6 months and 1 year	Absence of vitamin B12, vitamin D, folic acid, iron deficiencies
Clinical response	6 months and 1 year	≥ 30% decrease in average daily stool frequency and/or ≥ 30% decrease in average daily abdominal pain score and both not worse than baseline
Fecal calprotectin improvement	6 months and 1 year	50% or more improvement in faecal calprotectin or faecal calprotectin \<250 µg/g

Trial Locations

Locations (1)

University Hospital of Leuven; 🇧🇪 Leuven, Belgium