Status:
UNKNOWN
VSL#3 Treatment in Children With Crohn's Disease
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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 i...
Detailed Description
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 budeso...
Eligibility Criteria
Inclusion
- 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
- Treatment with 5-ASA, budesonide and imuran/6MP daily provided that the dose has remained stable for the 4 weeks (corticosteroids) or 12 weeks (for imuran/6MP) prior to inclusion. Children treated with other medications (such as anti-TNF or antibiotics including ciprofloxacilin or metronidazole) cannot enter this study.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00367705
Start Date
August 1 2009
End Date
December 1 2010
Last Update
August 18 2009
Active Locations (1)
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1
Hadassah Medical Organization,
Jerusalem, Israel, 91120