The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Crohn's Disease

Treatments: Dietary Supplement: VSL#3

Study type: Interventional

Funder types: Other

Identifiers

NCT01548014

2009-11-046

Details and patient eligibility

About

The purpose was to evaluate as to whether administration of infliximab of 12 week interval with supplementary VSL#3 is more effective or at least of similar efficacy when compared to conventional administration of infliximab only of 8 week interval.

Full description

The purpose of our study was to evaluate if supplementation of VSL#3 can improve treatment outcome for those pediatric Crohn's patients treated with infliximab every 12 weeks.

Enrollment: 1 estimated patient

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment
• confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion criteria

• patients who has proven to have infliximab antibody

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)