Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis

Crohn's Disease Clinical Trial

Official title:

Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00265772
• Other study ID #: NCNF0105
• Status: Recruiting
• Phase: Phase 4
• First received: December 14, 2005
• Last updated: December 14, 2005
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: November 2005
• Source: Hôpital Necker-Enfants Malades
• Contact: Frank M Ruemmele, MD PhD
• Phone: 33.1.44.49.44.12
• Email: frank.ruemmele[@]nck.ap-hop-paris.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Pediatric

Intervention

Drug:
• MODULEN IBD (R) (specific Enteral Nutrition)

• prednisolon

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades	Institut National de la Santé Et de la Recherche Médicale, France, Nestlé

Country where clinical trial is conducted

France, 

References & Publications (6)

Bannerjee K, Camacho-Hübner 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. — View 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. — View 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. French. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
Secondary	clinical remission (Harvey Bradshaw Index <5)
Secondary	biological remission (decrease of systemic and mucosal inflammatory markers)
Secondary	improvement of the anti-bacterial defense