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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease Pediatric | Drug: MODULEN IBD (R) (specific Enteral Nutrition) Drug: prednisolon | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2005 |
Study Completion Date : | April 2008 |

- Mucosal Healing (decrease >70% of the Crohn's disease endoscopic index score after 8 weeks of treatment)
- 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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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265772
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 |
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 |
Principal Investigator: | Frank M Ruemmele, MD PhD | Hôpital Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Service de Gastroenterologie pédiatrique, INSERM EMI0212, Paris, France |
ClinicalTrials.gov Identifier: | NCT00265772 |
Other Study ID Numbers: |
NCNF0105 |
First Posted: | December 15, 2005 Key Record Dates |
Last Update Posted: | December 15, 2005 |
Last Verified: | November 2005 |
enteral nutrition steroids mucosal healing |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Prednisolone |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |