Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIT group | Experimental | Patients treated with biological treatment and the FIT diet |
|
| Control group | No Intervention | Patients treated with biological treatment and the standard diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIT diet | Other | Dietary intervention as add-on therapy to biologicals |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João PG Sabino, MD PhD | Contact | 003216341770 | joao.sabino@uzleuven.be | |
| Isolde Aerden | Contact | isolde.aerden@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| João PG Sabino, MD PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Leuven | Recruiting | Leuven | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |