|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00265772 |
|
Date of registration:
|
14/12/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
|
|
Scientific title:
|
Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis |
|
Date of first enrolment:
|
November 2005 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00265772 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Frank M Ruemmele, MD PhD |
|
Address:
|
|
|
Telephone:
|
33.1.44.49.44.12 |
|
Email:
|
frank.ruemmele@nck.ap-hop-paris.fr |
|
Affiliation:
|
|
|
|
Name:
|
Frank M Ruemmele, MD PhD |
|
Address:
|
|
|
Telephone:
|
33.1.44.49.44.12 |
|
Email:
|
frank.ruemmele@nck.ap-hop-paris.fr |
|
Affiliation:
|
|
|
|
Name:
|
Frank M Ruemmele, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France |
|
|
Key inclusion & exclusion 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
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn's Disease
|
|
Pediatric
|
|
Intervention(s)
|
|
Drug: prednisolon
|
|
Drug: MODULEN IBD (R) (specific Enteral Nutrition)
|
|
Primary Outcome(s)
|
|
Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
|
|
Secondary Outcome(s)
|
|
clinical remission (Harvey Bradshaw Index <5)
|
|
improvement of the anti-bacterial defense
|
|
biological remission (decrease of systemic and mucosal inflammatory markers)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|