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Trial registered on ANZCTR


Registration number
ACTRN12616000500459p
Ethics application status
Not yet submitted
Date submitted
12/04/2016
Date registered
18/04/2016
Date last updated
18/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can BLIS K12 probiotics reduce recurrent tonsillitis in children?
Scientific title
BLIS probiotics for preventing recurrent tonsillitis in children
Secondary ID [1] 288983 0
None
Universal Trial Number (UTN)
U1111-1181-8556
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent tonsillitis in children 298383 0
Condition category
Condition code
Infection 298485 298485 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a placebo-controlled trial using BLIS K12, a commercially available oral probiotic. It contains a strain of S. salivarius at a concentration of at least 1x10^8 cf. per lozenge. Participants will be treated with 10 days of oral amoxycillin and then take one lozenge per day for 3 months or until their surgery. Adherence will be monitored by a patient diary and a return lozenge count at 1 months and 3 months of treatment. At each clinical assessment a throat swab will be taken and tested for the presence of BLIS K12 strain of S salivarius.
Intervention code [1] 294469 0
Treatment: Other
Comparator / control treatment
This is a double blinded, placebo-controlled trial. The placebo will be an identical product without the probiotic bacteria included.
Control group
Placebo

Outcomes
Primary outcome [1] 297967 0
Recurrence of tonsillitis. If a child has an episode of tonsillitis while on the trial they will be assessed by one of the ENT doctors ( Registrar or Consultant) for confirmation. We will use internationally determined diagnostic criteria as outlined in the protocol to determine the presence of absence of tonsillitis.
Timepoint [1] 297967 0
within 3 months of starting on trial
Secondary outcome [1] 322799 0
Carriage of BLIS K12 in the oropharynx.
At each clinical assessment a throat swab will be taken and tested for the presence of the BLIS K12 strain of S. salivarius by PCR
Timepoint [1] 322799 0
At the time of surgery for tonsillitis

Eligibility
Key inclusion criteria
Recurrent tonsillits > 5 episodes of tonsillitis in the preceding 12 months
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Immune deficiency or cystic fibrosis
Anatomical abnormalities of the upper airways

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Done by independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by an unblinded statistician who is not involved in the clinical care of the children. He will generate a randomisation table using computer software for each site where children are recruited. This table will be used by a blinded pharmacist to prepare the investigational product for the participant after enrolment in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a small study in children with recurrent tonsillitis 24 children with recurrent tonsillitis received a daily dose of BLIS K12 or placebo (Hale, Burton, Chilcott et al 2014). The rate of sore throats in the treatment group was 0.10 per month while in the placebo group it was 0.19 per month.
An Italian study demonstrated a 97% reduction in the incidence of pharyngitis caused by S. pyogenes in a group of children treated with BLIS K12 for 90 days when compared to historical rates of disaese in the group (Di Pierro, Colombo, Zanvit, Risso, & Rottoli, 2014).
A sample size of 35 per group will provide 90% power at an alpha of 0.05 to detect a 50% reduction in the number of episodes or tonsillitis if the background rate is 6 episodes per year and the children are followed for 3 months.
We will allow for a 12.5% drop out rate and plan to recruit 40 patients per group. The children are likely to be followed for a period longer than 3 months given the current waiting lists. This will increase the power of the study and provide a margin of error for any possible reduced effect size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2016
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 7808 0
New Zealand
State/province [1] 7808 0
Canterbury and Wellington

Funding & Sponsors
Funding source category [1] 293338 0
University
Name [1] 293338 0
University of Otago
Country [1] 293338 0
New Zealand
Funding source category [2] 293355 0
Commercial sector/Industry
Name [2] 293355 0
BLIS Technologies
Country [2] 293355 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 292181 0
None
Name [1] 292181 0
Address [1] 292181 0
Country [1] 292181 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294806 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 294806 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294806 0
New Zealand
Date submitted for ethics approval [1] 294806 0
18/04/2016
Approval date [1] 294806 0
Ethics approval number [1] 294806 0

Summary
Brief summary
Recurrent tonsillitis is one of the major indication for tonsillectomy in children. Each year the Department of Otolaryngology at CDHB see in excess of 90 children who require tonsillectomy because of recurrent tonsillitis. The current waiting list for tonsillectomy is 18 weeks. This is well above the recommended waiting times and reflects increasing pressure on the surgical waiting lists for children needing tonsillectomy.

The primary objective of this research is to establish if the use of probiotics can reduce the burden of disease, and as a consequence the need for surgical intervention, in children with recurrent tonsillitis.

We will run a randomized double-blinded controlled trial to address the following hypothesis:
1) BLIS K12 probiotics taken orally reduce the incidence of recurrence of tonsillitis in children who have recurrent tonsillitis

The BLIS Tonsillitis trial will recruit patients from June 2016 until January 2017 with final follow up of patients through until April 2017. It will require approximately 40 patients per group for each study with 5 months of follow up per patient. Children will be recruited from two sites – the CDHB and CCDHB.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 65126 0
Dr Tony Walls
Address 65126 0
Department of Paediatrics
University of Otago, Christchurch
PO Box 4345 Christchurch Mail Centre
Christchurch 8140
Country 65126 0
New Zealand
Phone 65126 0
+64 3 378 6536
Fax 65126 0
+ 64 3 378 6355
Email 65126 0
[email protected]
Contact person for public queries
Name 65127 0
Tony Walls
Address 65127 0
Department of Paediatrics
University of Otago, Christchurch
PO Box 4345 Christchurch Mail Centre
Christchurch 8140
Country 65127 0
New Zealand
Phone 65127 0
+64 3 378 6536
Fax 65127 0
+ 64 3 378 6355
Email 65127 0
[email protected]
Contact person for scientific queries
Name 65128 0
Tony Walls
Address 65128 0
Department of Paediatrics
University of Otago, Christchurch
PO Box 4345 Christchurch Mail Centre
Christchurch 8140
Country 65128 0
New Zealand
Phone 65128 0
+64 3 378 6536
Fax 65128 0
+ 64 3 378 6355
Email 65128 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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