Crohn's Disease
Conditions
Keywords
Crohn's disease, VSL #3, infliximab
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.
Interventions
DIETARY_SUPPLEMENTVSL#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).
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYon Ho Choe, MD.PHD
Backup ContactYoo Min Lee, MD
Outcome results
None listed