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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by YonHo Choe, Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548014
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
YonHo Choe, Samsung Medical Center
  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: 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

Resource links provided by NLM:


Further study details as provided by YonHo Choe, 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 ]
    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

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
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
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


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

Responsible Party: YonHo Choe, Pediatrics, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01548014     History of Changes
Other Study ID Numbers: 2009-11-046
First Submitted: February 17, 2012
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by YonHo Choe, 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
Gastrointestinal Agents
Antirheumatic Agents