Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265772
Status:
UNKNOWN
Last Update Posted:
2005-12-15
First Post:
2005-12-14
Brief Title:
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohns Disease - the Molecular Basis
Sponsor:
Hôpital Necker-Enfants Malades
Organization:
Hôpital Necker-Enfants Malades
Study Overview
Official Title:
Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohns Disease - the Molecular Basis
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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 Crohns 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None