MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE

Conditions: Moderate-to-severe active Crohn`sdisease.
MedDRA version: 9.1Level: LLTClassification code 10011398Term: Crohn's

Registration Number: EUCTR2008-006484-36-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. diagnosis of CD made at least 3 months before the enrolment; 2. disease activity score in the moderate-to-severe range; 3. ability to start oral formula for nutritional therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Fistulizing and/or anorectal CD, stenosing CD, pre-existing systemic disease, hepatic or renal dysfunction, lung disease, systemic infection, suspected pregnancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The proportion of patients with both clinical remission and intestinal mucosa healing (as documented by endoscopy and histology) at the end of the induction phase, as well as at the end of maintaining remission phase;Secondary Objective: the mean changes in clinical and laboratory indexes of disease activity, the mean change in anthropometric parameters, the safety profile and the costs of the two<br>treatment regimens, and finally, changes in the intestinal mucosa expression of pro-inflammatory cytokines.;Primary end point(s): The study aims at comparing the efficacy of nutritional therapy alone (a polymeric formula given orally,<br>without adding any drug) with biological therapy (intravenous infusions of a chimeric monoclonal antibody anti-TNFalpha) in inducing and maintaining remission in children with moderate-to-severe active Crohn`s<br>disease (CD).

Secondary Outcome Measures