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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Hôpital Necker-Enfants Malades.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Nestlé
Information provided by:
Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier:
NCT00265772
First received: December 14, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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 Intervention Phase
Crohn's Disease
Pediatric
Drug: MODULEN IBD (R) (specific Enteral Nutrition)
Drug: prednisolon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hôpital Necker-Enfants Malades:

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

Estimated Enrollment: 24
Study Start Date: November 2005
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265772

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

Publications:
ClinicalTrials.gov Identifier: NCT00265772     History of Changes
Other Study ID Numbers: NCNF0105
Study First Received: December 14, 2005
Last Updated: December 14, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Methylprednisolone acetate
Prednisolone acetate
Anti-Inflammatory Agents
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 20, 2014