NCT00367705

Brief Summary

Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).

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
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2006

Enrollment Period

1.1 years

First QC Date

August 22, 2006

Last Update Submit

August 16, 2009

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • remission

    1 year

Study Arms (2)

T

ACTIVE COMPARATOR

VSL-#3

Dietary Supplement: VSL#3®

P

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

VSL#3®DIETARY_SUPPLEMENT

1-2 sachets/day per os, 6 months

T
PlaceboDIETARY_SUPPLEMENT

1-2 sachets/day per os, 6 months

Also known as: placebo powder
P

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged 6 - 18 years
  • Previous diagnosis of Crohn's disease or newly diagnosed with symptoms for at least three months before recruitment to the study.The diagnosis of CD is established by:
  • history and symptoms of the disease
  • endoscopy/histology or radiology with negative stool culture.
  • Written informed consent by parent
  • PCDAI \> 12.5 and \< 30

You may not qualify if:

  • Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture
  • Imminent surgery
  • Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial.
  • Participation in another clinical trial within the last 30 days.
  • Patients should not take antibiotics during the study.
  • Patients should not take opioids, cholestyramine, ursodeoxycholic acid during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Gionchetti P, Rizzello F, Lammers KM, Morselli C, Sollazzi L, Davies S, Tambasco R, Calabrese C, Campieri M. Antibiotics and probiotics in treatment of inflammatory bowel disease. World J Gastroenterol. 2006 Jun 7;12(21):3306-13. doi: 10.3748/wjg.v12.i21.3306.

    PMID: 16733845BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • David Branski, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Michael Wilschanski, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Branski, MD

CONTACT

00972-2-6777543branski@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

August 18, 2009

Record last verified: 2006-08

Locations

IL(1)