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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Société des Produits Nestlé (SPN) | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MODULEN IBD (R) (specific Enteral Nutrition) | Drug | |||
| prednisolon | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| clinical remission (Harvey Bradshaw Index <5) | ||
| biological remission (decrease of systemic and mucosal inflammatory markers) | ||
| improvement of the anti-bacterial defense |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Frank M Ruemmele, MD PhD | Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212 | Recruiting | Paris | F-75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15076624 | Background | 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. | |
| 10896064 | Background |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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. |
| 10861265 | 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. |
| 3123302 | 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. |
| 10700682 | 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. |
| 11915490 | 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. |
| D007410 | Intestinal Diseases |