Back to resultsThe Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VSL#3
Sponsored by
About this trial
This is an interventional supportive care trial for Crohn's Disease focused on measuring Crohn's disease, VSL #3, infliximab
Eligibility Criteria
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
Sites / Locations
- Samsung Medical CenterRecruiting
Outcomes
Primary Outcome Measures
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-α, IL-8, INF-γ, and endoscopic findings (Simple Endoscopic Score for Crohn's Disease was used) were assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT01548014
First Posted
February 17, 2012
Last Updated
March 7, 2012
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01548014
Brief Title
The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, VSL #3, infliximab
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL#3
Other Intervention Name(s)
VSL#3 : the living shield(probiotics)
Intervention Description
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).
Primary Outcome Measure Information:
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
Description
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
Time Frame
1-year treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yon Ho Choe, MD.PHD
Phone
82-10-9933-3527
Email
Yonho.choe@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yoo Min Lee, MD
Phone
82-10-8924-8230
Email
flana512@naver.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease
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