K50
Conditions
Interventions
Group 1: Before Therapy:
- medical history and examination, medical file data
- disease activity scoring
- ultrasound
- blood values (count and inflammation)
- stool sample (inflammation, microbiota)
Sponsors
Charité - Universitätsmedizin BerlinMedizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie (inkl. Arbeitsbereich Ernährungsmedizin)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - clinical, endoscopical and histological diagnosed Crohn's disease - last biological therapy over 4 weeks ago - age of at least 18 and written consent - inital Harvey-Bradshaw-Index >5
Exclusion criteria
Exclusion criteria: - isolated upper GI-disease or carrier of a stoma cannot participate as clinical scores do not work for them. - (cortisone or azathioprine treatment are no exclusion criteria.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the response based on a score decline in the Harvey-Bradshaw-Index 6 weeks after adalimumab induction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decline in laboratory values (CRP, white blood cell count, calprotectin). Decline in Limberg score (ultrasound). Response based on a score decline in the Harvey-Bradshaw-Index 12 weeks after adalimumab induction. | — |
Countries
Germany
Contacts
Public ContactBosse Jessen
Charité - Universitätsmedizin BerlinMedizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie (inkl. Arbeitsbereich Ernährungsmedizin)
Outcome results
None listed