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

March 7, 2012 updated by: YonHo Choe, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-year treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-11-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on VSL#3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe