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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014