K50.9
Conditions
Interventions
Group 1: Non-interventional study with children and adolescents treated for six to eight weeks with exclusive enteral nutrition for induction of remission of active crohn's disease. Before initiation
Sponsors
Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie
Eligibility
Sex/Gender
All
Age
6 Years to 20 Years
Inclusion criteria
Inclusion criteria: - Patients suffering from active inflammatory bowel disease and need to be treated with exclusive enteral nutrition therapy, steroids or biologicals; - Diagnosis confirmed by Porto diagnostic criteria; - informed consent of patients (> 12 years of age) and parents.
Exclusion criteria
Exclusion criteria: Changes in the immunosuppressive medication during the last three month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters will be evaluated before and 2-6 weeks after initiation of therapy: 1. Gut microbiome composition before and during therapy (method: sequencing). 2. Mucosal inflammation on molecular and cellular level (methods: quantitative PCR, immunohistochemistry). 3. Phenotype and Function of peripheral blood mononuclear cells (methods: FACS analysis, ELISA, qPCR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and laboratory remission after 2-6 weeks of therapy; methods: history and examination, disease activity score, stool and lab work for inflammatory markers; | — |
Countries
Germany
Contacts
Public ContactTobias Schwerd
Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie
Outcome results
None listed