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

For children with quiescent Crohn's disease, will a 3 month period of receiving the probiotic VSL#3, as compared to a period of 3 months receiving a placebo, prevent disease relapse

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001268932

Enrollment

Registered

2011-12-12

Start date

2003-11-10

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 of the treatment arms Arm 1 Probiotics (Take one to two sachet(s) mixed with food once daily for 3 months, followed by; Washout (1 month), followed by; Placebo (Take one to two sachet(s) mixed with food once daily for 3 months Arm 2 Placebo (Take one to two sachet(s) mixed with food once daily for 3 months, followed by Washout (1 month), followed by: Probiotics (Take one to two sachet(s) mixed with food once daily for 3 months

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Healthy volunteers

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

Outcome results