NCT01548014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

2.7 years

First QC Date

February 17, 2012

Last Update Submit

March 7, 2012

Conditions

Crohn's Disease

Keywords

Crohn's diseaseVSL #3infliximab

Outcome Measures

Primary Outcomes (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

    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

Interventions

VSL#3DIETARY_SUPPLEMENT

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).

Also known as: VSL#3 : the living shield(probiotics)

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • patients who has proven to have infliximab antibody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Yon Ho Choe, MD.PHD

CONTACT

82-10-9933-3527Yonho.choe@samsung.com

Yoo Min Lee, MD

CONTACT

82-10-8924-8230flana512@naver.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrics

Study Record Dates

First Submitted

February 17, 2012

First Posted

March 8, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

January 1, 2016

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

KR(1)