A Double Blind, Randomised, Placebo Controlled Trial to Determine the Efficacy of the probiotic VSL#3 in Preventing Relapse in Children with Crohn’s Disease - 3 month crossover study
Not Applicable
Completed
- Conditions
- Crohn?s DiseaseOral and Gastrointestinal - Crohn's disease
- Registration Number
- ACTRN12611001268932
- Lead Sponsor
- Sydney Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Consenting outpatients
Established Diagnosis of Crohn’s disease
PCDAI <15
Exclusion Criteria
Established diagnosis of ulcerative colitis
Use of systemic antibiotics, other probiotics or probiotic agents within 2 weeks
Isolated perianal disease
Intend to continue concurrent administration of alternative probiotic therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease relapse as assessed by a Paediatric Crohn's Disease Activity Index (PCDAI) >15[Baseline, month 1, month 2 and month 3 for each study Arm]
- Secondary Outcome Measures
Name Time Method