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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01548014
Date of registration: 17/02/2012
Prospective Registration: No
Primary sponsor: Samsung Medical Center
Public title: The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease
Scientific 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
Date of first enrolment: January 2010
Target sample size: 1
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  Phase 3
Countries of recruitment
Korea, Republic of
Name:     Yon Ho Choe, MD.PHD
Telephone: 82-10-9933-3527
Key inclusion & exclusion 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

Exclusion Criteria:

- patients who has proven to have infliximab antibody

Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Dietary Supplement: VSL#3
Primary Outcome(s)
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 [Time Frame: 1-year treatment period]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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