Crohn Disease, Diet, Healthy, Inflammatory Bowel Diseases
Conditions
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.
Interventions
OTHERFIT diet
Dietary intervention as add-on therapy to biologicals
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | 6 months and 1 year | PRO2≤8 |
| Steroid-free clinical remission | 6 months and 1 year | PRO2≤8, no steroids |
| Endoscopic remission | 1 year | SES-CD \<2 |
| Endoscopic improvement | 1 year | drop in SES-CD with at least 50% |
| 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 |
| Number of participants without nutritional deficiencies | 6 months and 1 year | Absence of vitamin B12, vitamin D, folic acid, iron deficiencies |
| Fatigue | 6 months and 1 year | 30% or more improvement in IBD Disk energy score |
| Health-related quality of life | 6 months and 1 year | 30% or more improvement in overall IBD Disk score |
| CRP improvement | 6 months and 1 year | 50% or more improvement in CRP or CRP \<5 mg/L |
Countries
Belgium
Contacts
Primary ContactJoão PG Sabino, MD PhD
Backup ContactIsolde Aerden
Outcome results
None listed