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

NCT00265772 | Unknown Phase 4

• 1 other identifier: NCNF0105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Pediatric

Keywords

enteral nutrition; steroids; mucosal healing

Outcome Measures

Primary Outcomes (1)

• Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)

Secondary Outcomes (3)

• clinical remission (Harvey Bradshaw Index <5)

• biological remission (decrease of systemic and mucosal inflammatory markers)

• improvement of the anti-bacterial defense

Interventions

MODULEN IBD (R) (specific Enteral Nutrition) DRUG

prednisolon DRUG

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Crohn's disease active disease small bowel involvement

Sponsors & Collaborators

• Hôpital Necker-Enfants Malades: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212

Paris, F-75015, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 15076624 BACKGROUND

• 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.

  PMID: 10896064 BACKGROUND

• 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.

  PMID: 10861265 BACKGROUND

• 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.

  PMID: 3123302 BACKGROUND

• 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.

  PMID: 10700682 BACKGROUND

• 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.

  PMID: 11915490 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Frank M Ruemmele, MD PhD

  Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank M Ruemmele, MD PhD

CONTACT

33.1.44.49.44.12; frank.ruemmele@nck.ap-hop-paris.fr

Laurence Beck, PhD

CONTACT

33.1.60.53.41.52; laurence.beck@fr.nestle.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: November 1, 2005
• Study Completion: April 1, 2008
• Last Updated: December 15, 2005

Record last verified: 2005-11

Locations

FR (1)