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 – 12-month long term study

Not Applicable

Completed

• Conditions: Crohn's disease; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12611001267943
• Lead Sponsor: Sydney Chidlren's hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Consenting outpatients
Established Diagnosis of Crohn’s disease
Ceased use of systemic antibiotics or other probiotic of probiotic agents in any form at least four weeks prior to enrolment in study

Exclusion Criteria

Established diagnosis of ulcerative colitis
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 3, month 6, month 9, month 12]