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

This study is currently recruiting participants.
Verified March 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
YonHo Choe, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01548014
First received: February 17, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Dietary Supplement: VSL#3
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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 [ Time Frame: 1-year treatment period ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 1
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
    Other Name: VSL#3 : the living shield(probiotics)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548014

Contacts
Contact: Yon Ho Choe, MD.PHD 82-10-9933-3527 Yonho.choe@samsung.com
Contact: Yoo Min Lee, MD 82-10-8924-8230 flana512@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: YonHo Choe, Pediatrics, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01548014     History of Changes
Other Study ID Numbers: 2009-11-046
Study First Received: February 17, 2012
Last Updated: March 7, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Crohn's disease
VSL #3
infliximab

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 22, 2014