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

Crohn's Disease Clinical Trial

Official title:

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: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01548014
• Other study ID #: 2009-11-046
• Status: Recruiting
• Phase: Phase 3
• First received: February 17, 2012
• Last updated: March 7, 2012
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: March 2012
• Source: Samsung Medical Center
• Contact: Yon Ho Choe, MD.PHD
• Phone: 82-10-9933-3527
• Email: Yonho.choe[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: January 2016
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• VSL#3
children with severe Crohn's disease were assigned in a 1:1 ratio with either IFX 5 mg/kg q 12 weeks + concurrent immunomodulator + VSL#3 (4 sachets of 450 x 109 organisms per day) (Group A), or IFX 5 mg/kg q 8 weeks + concurrent immunomodulator (Group B).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease Activity Index (PCDAI) scores, hematocrit, albumin, ESR, CRP, TNF-a, IL-8, INF-?, and endoscopic findings (Simple Endoscopic Score for Crohn's Disease was used) were assessed	1-year treatment period	Yes