Bowel Disease Inflammatory Bowel Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: · Endoscopically or histologically proven Crohn*s disease or ulcerative colitis before 3 months prior to randomization · Age 18-70 years · Written informed consent · Adequate contraception for males and females during treatment and follow up (written confirmation) · All therapy is permitted concomitant therapy · Patients must be hospitalized
Exclusion criteria
Exclusion criteria: · Pregnancy, breast-feeding · Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study · Total parental nutrition · Bowel perforation · Short bowel · Neoplastic condition of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction of hospital stay in days of 30% | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life and psychopathology by psychological assessment using the IBDQ questionnaire | — |
Countries
Netherlands