Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
Primary Purpose
Crohn's Disease, Pediatric
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MODULEN IBD (R) (specific Enteral Nutrition)
prednisolon
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring enteral nutrition, steroids, mucosal healing
Eligibility Criteria
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
Sites / Locations
- Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212Recruiting
Outcomes
Primary Outcome Measures
Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
Secondary Outcome Measures
clinical remission (Harvey Bradshaw Index <5)
biological remission (decrease of systemic and mucosal inflammatory markers)
improvement of the anti-bacterial defense
Full Information
NCT ID
NCT00265772
First Posted
December 14, 2005
Last Updated
December 14, 2005
Sponsor
Hôpital Necker-Enfants Malades
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT00265772
Brief Title
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
Official Title
Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hôpital Necker-Enfants Malades
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Société des Produits Nestlé (SPN)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Pediatric
Keywords
enteral nutrition, steroids, mucosal healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MODULEN IBD (R) (specific Enteral Nutrition)
Intervention Type
Drug
Intervention Name(s)
prednisolon
Primary Outcome Measure Information:
Title
Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
Secondary Outcome Measure Information:
Title
clinical remission (Harvey Bradshaw Index <5)
Title
biological remission (decrease of systemic and mucosal inflammatory markers)
Title
improvement of the anti-bacterial defense
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank M Ruemmele, MD PhD
Phone
33.1.44.49.44.12
Email
frank.ruemmele@nck.ap-hop-paris.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Beck, PhD
Phone
33.1.60.53.41.52
Email
laurence.beck@fr.nestle.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M Ruemmele, MD PhD
Organizational Affiliation
Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212
City
Paris
ZIP/Postal Code
F-75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank M Ruemmele, MD PhD
Phone
33.1.44.49.44.12
Email
frank.ruemmele@nck.ap-hop-paris.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
15076624
Citation
Bannerjee K, Camacho-Hubner C, Babinska K, Dryhurst KM, Edwards R, Savage MO, Sanderson IR, Croft NM. Anti-inflammatory and growth-stimulating effects precede nutritional restitution during enteral feeding in Crohn disease. J Pediatr Gastroenterol Nutr. 2004 Mar;38(3):270-5. doi: 10.1097/00005176-200403000-00007.
Results Reference
background
PubMed Identifier
10896064
Citation
Heuschkel RB, Menache CC, Megerian JT, Baird AE. Enteral nutrition and corticosteroids in the treatment of acute Crohn's disease in children. J Pediatr Gastroenterol Nutr. 2000 Jul;31(1):8-15. doi: 10.1097/00005176-200007000-00005.
Results Reference
background
PubMed Identifier
10861265
Citation
Heuschkel RB, MacDonald TT, Monteleone G, Bajaj-Elliott M, Smith JA, Pender SL. Imbalance of stromelysin-1 and TIMP-1 in the mucosal lesions of children with inflammatory bowel disease. Gut. 2000 Jul;47(1):57-62. doi: 10.1136/gut.47.1.57.
Results Reference
background
PubMed Identifier
3123302
Citation
Belli DC, Seidman E, Bouthillier L, Weber AM, Roy CC, Pletincx M, Beaulieu M, Morin CL. Chronic intermittent elemental diet improves growth failure in children with Crohn's disease. Gastroenterology. 1988 Mar;94(3):603-10. doi: 10.1016/0016-5085(88)90230-2.
Results Reference
background
PubMed Identifier
10700682
Citation
Ruemmele FM, Roy CC, Levy E, Seidman EG. Nutrition as primary therapy in pediatric Crohn's disease: fact or fantasy? J Pediatr. 2000 Mar;136(3):285-91. doi: 10.1067/mpd.2000.104537. No abstract available.
Results Reference
background
PubMed Identifier
11915490
Citation
Gailhoustet L, Goulet O, Cachin N, Schmitz J. [Study of psychological repercussions of 2 modes of treatment of adolescents with Crohn's disease]. Arch Pediatr. 2002 Feb;9(2):110-6. doi: 10.1016/s0929-693x(01)00717-5. French.
Results Reference
background
Learn more about this trial
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
We'll reach out to this number within 24 hrs