Crohn's Disease, Pediatric
Conditions
Keywords
enteral nutrition, steroids, mucosal healing
Brief summary
The primary purpose of this study is to compare the efficacy of enteral nutrition compared to steroids in inducing remission of active pediatric Crohn's disease. The main hypothesis of this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do not. This effect may be related to a change of the commensal flora during enteral nutrition.
Detailed description
The precise and exact cause of Crohn's disease (CD) remains still unknown. However, recent data point out to an inappropriate and exaggerated inflammatory response of the intestinal mucosal immune system toward intestinal commensal flora as initial trigger. Several strategies were developed in the treatment of active CD. Anti-inflammatory drugs such as steroids proved to be very helpful in the induction of a primary remission as is the use of exclusive enteral nutrition. Besides a long standing experience with EN in the management of CD in several centres, the mode of action and the molecular mechanisms of a specific EN, such as Modulen IBD ® remain still unknown. The ultimate aim of this study is to compare the efficacy of Modulen IBD ® in inducing remission compared to steroids with a detailed analysis of the mucosal repair and anti-bacterial defence mechanisms within the inflamed intestinal mucosa and the composition of the commensal flora before and during therapy. This approach may help to elucidate the interaction between the intestinal mucosa and the commensal flora during the onset of CD and induction of remission.
Interventions
DRUGMODULEN IBD (R) (specific Enteral Nutrition)
DRUGprednisolon
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Société des Produits Nestlé (SPN)
Hôpital Necker-Enfants Malades
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Crohn's disease active disease small bowel involvement
Exclusion criteria
antibiotic therapy within 4 weeks prior to inclusion immunosuppressive therapy within 4 weeks prior to inclusion not willing to collaborate isolated oral or perianal involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical remission (Harvey Bradshaw Index <5) | — |
| biological remission (decrease of systemic and mucosal inflammatory markers) | — |
| improvement of the anti-bacterial defense | — |
Countries
France
Contacts
Primary ContactFrank M Ruemmele, MD PhD
Backup ContactLaurence Beck, PhD
Outcome results
None listed