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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy

Intervention / Treatment
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* Other: FIT diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIT group<br>Patients treated with biological treatment and the FIT diet | Other: FIT diet<br>* Dietary intervention as add-on therapy to biologicals<br>|
| No Intervention: Control group<br>Patients treated with biological treatment and the standard diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steroid-free clinical and biochemical remission | 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. | Month 6 | 

Secondary Outcome Measures

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