None listed
Conditions
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.
Interventions
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 fo
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Recurrent tonsillits > 5 episodes of tonsillitis in the preceding 12 months
Exclusion criteria
Immune deficiency or cystic fibrosis Anatomical abnormalities of the upper airways
Outcome results
None listed