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Trial registered on ANZCTR


Registration number
ACTRN12611001268932
Ethics application status
Approved
Date submitted
6/12/2011
Date registered
12/12/2011
Date last updated
12/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 273535 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn?s Disease 279337 0
Condition category
Condition code
Oral and Gastrointestinal 279521 279521 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 283847 0
Prevention
Comparator / control treatment
Maize starch (included as filler in probiotic)
Control group
Placebo

Outcomes
Primary outcome [1] 286091 0
Disease relapse as assessed by a Paediatric Crohn's Disease Activity Index (PCDAI) >15
Timepoint [1] 286091 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [1] 295104 0
Height will be measured using a calibrated stadiometer, with measurements converted to age appropriate Z scores using the Center for Disease control 2000 as reference.
Timepoint [1] 295104 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [2] 295105 0
Weight will be measured using a calibrated scales, with measurements converted to age appropriate Z scores using the Center for Disease control 2000 as reference.
Timepoint [2] 295105 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [3] 295106 0
Body Mass Index
Timepoint [3] 295106 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [4] 295107 0
Quality of Life questionnaire
Timepoint [4] 295107 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [5] 295108 0
Physicians Global Assessment
Timepoint [5] 295108 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [6] 295109 0
Blood Platelets will be measured at the time of routine clinical follow-up. Peripheral blood will be collected with Blood Platelets measured using routine laboratory test at the South Eastern Area Laboratory Service
Timepoint [6] 295109 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [7] 295110 0
Serum albumin will be measured at the time of routine clinical follow-up. Peripheral blood will be collected with serum albumin measured using routine laboratory test at the South Eastern Area Laboratory Service
Timepoint [7] 295110 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [8] 295111 0
Serum C-reactive Protein will be measured at the time of routine clinical follow-up. Peripheral blood will be collected with Serum C-reactive Protein measured using routine laboratory test at the South Eastern Area Laboratory Service
Timepoint [8] 295111 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [9] 295112 0
Blood Erythrocyte Sedimentation Rate will be measured at the time of routine clinical follow-up. Peripheral blood will be collected with Blood Erythrocyte Sedimentation Rate measured using routine laboratory test at the South Eastern Area Laboratory Service
Timepoint [9] 295112 0
Baseline, month 1, month 2 and month 3 for each study Arm
Secondary outcome [10] 295113 0
Faecal S100A12 will be measured in feaces collected at the time of routine clinical follow-up. Faecal S100A12 will be measured by an in-house validated ELISA
Timepoint [10] 295113 0
Baseline, month 1, month 2 and month 3 for each study Arm

Eligibility
Key inclusion criteria
Consenting outpatients
Established Diagnosis of Crohn’s disease
PCDAI <15
Minimum age
4 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children attending the Sydney Children’s hospital IBD clinic who meet the enrolment criteria will be invited to participate in the study

Patients will be allocated to a treatment Arm will by the pharmacist dispensing the probiotics. The pharmacist will use a randomisation list to randomly assign patients to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation undertaken by pharmacist using a computer to generate random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4772 0
2031
Recruitment postcode(s) [2] 4773 0
4072

Funding & Sponsors
Funding source category [1] 284324 0
Self funded/Unfunded
Name [1] 284324 0
Address [1] 284324 0
Country [1] 284324 0
Primary sponsor type
Hospital
Name
Sydney Children's Hospital
Address
High Street
Randwick
NSW
Australia
2031
Country
Australia
Secondary sponsor category [1] 283268 0
None
Name [1] 283268 0
Address [1] 283268 0
Country [1] 283268 0
Other collaborator category [1] 260371 0
Individual
Name [1] 260371 0
Dr Daniel Lemberg
Address [1] 260371 0
Department of Peadiatrics
Sydney Children's hospital
Randwick, NSW
2031
Daniel.Lemberg@SESIAHS.HEALTH.NSW.GOV.AU
Ph: +61 2 9382 0278
Fax: +61 2 9382 1574
Country [1] 260371 0
Australia
Other collaborator category [2] 260372 0
Individual
Name [2] 260372 0
Dr Rebecca Hill
Address [2] 260372 0
The School of Medicine
University of Qld
Brisbane
St Lucia, QLD
4072
Rj.hill@ uq.edu.au
Ph: +61 7 3365 5351
Fax: +61 7 3346 4684
Country [2] 260372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286286 0
Human Research Ethics Committee South Eastern Sydney Area Health Service
Ethics committee address [1] 286286 0
Room G71, EBB
Cnr High& Avoca Strs
Randwick NSW 2031
Ethics committee country [1] 286286 0
Australia
Date submitted for ethics approval [1] 286286 0
Approval date [1] 286286 0
01/05/2003
Ethics approval number [1] 286286 0
03-206

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33496 0
Address 33496 0
Country 33496 0
Phone 33496 0
Fax 33496 0
Email 33496 0
Contact person for public queries
Name 16743 0
A/Prof Andrew Day
Address 16743 0
Department of Paediatics
University of Otago, Christchurch
PO Box 4345, Christchurch Mail Centre
Christchurch
8140
Country 16743 0
New Zealand
Phone 16743 0
+64 3 364 1644
Fax 16743 0
+64 3 378 6355
Email 16743 0
andrew.day@otago.ac.nz
Contact person for scientific queries
Name 7671 0
A/Prof Andrew Day
Address 7671 0
Department of Paediatics
University of Otago, Christchurch
PO Box 4345, Christchurch Mail Centre
Christchurch
8140
Country 7671 0
New Zealand
Phone 7671 0
+64 3 364 1644
Fax 7671 0
+64 3 378 6355
Email 7671 0
andrew.day@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary