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

For Children with Crohn’s disease, will the probiotic VSL#3 taken over a 12 month period compared to children with Crohn’s disease taking a placebo for 12 months, prevent disease relapse

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001267943

Enrollment

Registered

2011-12-12

Start date

2004-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is experimental human and animal data to support a role for bacteria and / or bacterial products in the cause of inflammatory bowel disease (IBD), especially Crohn’s disease. Furthermore antibiotics have been shown in some cases to provide beneficial effects in IBD. In the last few years there has been increasing interest in probiotic agents in the treatment of various gastrointestinal conditions. The aims of this trial are to 1) determine the efficacy of probiotic therapy upon clinical parameters in children with IBD 2) determine the efficacy of probiotic therapy upon quality of life parameters in children with IBD 3) define the effects of probiotic therapy in children with IBD upon markers of inflammation both standard and novel 4) define the effects of probiotic therapy in children with IBD upon gut bacteria and 5) to document the tolerance and acceptability of probiotic therapy in children with IBD

Interventions

Patients will be randomised into either treatment arm Arm 1 – Active probiotics agent Patients received the active probiotic agent for the entire 12 month trial period. Standard dosing was 1 probiotic sachet (containing 900 million organisms plus maize starch) taken once daily for 12 months Arm 2 – Placebo Patients will receive the placebo for the entire 12 month trial period. Standard dosing was 1 placebo sachet (containing maize starch) taken once daily for 12 months. Note: the probiotic

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Healthy volunteers

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

Outcome results