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

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ClinicalTrials.gov Identifier: NCT00265772
Recruitment Status : Unknown
Verified November 2005 by Hôpital Necker-Enfants Malades.
Recruitment status was:  Recruiting
First Posted : December 15, 2005
Last Update Posted : December 15, 2005
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Nestlé
Information provided by:
Hôpital Necker-Enfants Malades

Tracking Information
First Submitted Date  ICMJE December 14, 2005
First Posted Date  ICMJE December 15, 2005
Last Update Posted Date December 15, 2005
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
  • clinical remission (Harvey Bradshaw Index <5)
  • biological remission (decrease of systemic and mucosal inflammatory markers)
  • improvement of the anti-bacterial defense
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
Official Title  ICMJE Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn's Disease
  • Pediatric
Intervention  ICMJE
  • Drug: MODULEN IBD (R) (specific Enteral Nutrition)
  • Drug: prednisolon
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: December 14, 2005)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265772
Other Study ID Numbers  ICMJE NCNF0105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hôpital Necker-Enfants Malades
Collaborators  ICMJE
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Nestlé
Investigators  ICMJE
Principal Investigator: Frank M Ruemmele, MD PhD Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France
PRS Account Hôpital Necker-Enfants Malades
Verification Date November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP