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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease; Pediatric	Drug: MODULEN IBD (R) (specific Enteral Nutrition); Drug: prednisolon	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
Study Start Date :	November 2005
Study Completion Date :	April 2008

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. clinical remission (Harvey Bradshaw Index <5)
2. biological remission (decrease of systemic and mucosal inflammatory markers)
3. improvement of the anti-bacterial defense

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Frank M Ruemmele, MD PhD	33.1.44.49.44.12	frank.ruemmele@nck.ap-hop-paris.fr
Contact: Laurence Beck, PhD	33.1.60.53.41.52	laurence.beck@fr.nestle.com

Locations

France
Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212	Recruiting
Paris, France, F-75015
Contact: Frank M Ruemmele, MD PhD 33.1.44.49.44.12 frank.ruemmele@nck.ap-hop-paris.fr

Sponsors and Collaborators

Hôpital Necker-Enfants Malades

Institut National de la Santé Et de la Recherche Médicale, France

Nestlé

Investigators

Principal Investigator:	Frank M Ruemmele, MD PhD	Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00265772 History of Changes
Other Study ID Numbers:	NCNF0105
First Posted:	December 15, 2005
Last Update Posted:	December 15, 2005
Last Verified:	November 2005

Keywords provided by Hôpital Necker-Enfants Malades:

enteral nutrition; steroids; mucosal healing

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Prednisolone	Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents