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

Phase 4

• Conditions: Crohn's Disease; Pediatric

• Registration Number: NCT00265772
• Lead Sponsor: Hôpital Necker-Enfants Malades

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 Timeline

• Status Verified: 2005-11
• Study Start: 2005-11
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Last Update Submitted: 2005-12-14
• Study First Posted: 2005-12-15
• Last Update Posted: 2005-12-15
• Study Completion: 2008-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
clinical remission (Harvey Bradshaw Index <5)
biological remission (decrease of systemic and mucosal inflammatory markers)
improvement of the anti-bacterial defense

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212; 🇫🇷 Paris, France