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

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ClinicalTrials.gov Identifier: NCT01548014
Recruitment Status : Unknown
Verified March 2012 by YonHo Choe, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
YonHo Choe, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: VSL#3 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548014

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

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

Responsible Party: YonHo Choe, Pediatrics, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01548014     History of Changes
Other Study ID Numbers: 2009-11-046
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by YonHo Choe, Samsung Medical Center:
Crohn's disease
VSL #3

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents