FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006484-36-IT
Enrollment
Unknown
Registered
2009-04-24
Start date
2009-04-16
Completion date
Unknown
Last updated
2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe active Crohn`s disease. MedDRA version: 9.1 Level: LLT Classification code 10011398 Term: Crohn's

Interventions

Trade Name: REMICADE Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 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, 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 disease (CD).—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026