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

Phase 3

• Conditions: Crohn's Disease

• Registration Number: NCT01548014
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-02-17
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08
• Primary Completion: 2012-09
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in Frequency of Infliximab Administration from q 8 Weeks to q 12 Weeks in Children with Crohn's Disease Receiving Probiotic VSL#3 Supplementation	1-year treatment period	Disease Activity Index (PCDAI) scores, hematocrit, albumin, ESR, CRP, TNF-α, IL-8, INF-γ, and endoscopic findings (Simple Endoscopic Score for Crohn's Disease was used) were assessed

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of