The BLIS study v1
Research type
Research Study
Full title
A feasibility study assessing compliance, acceptability and colonisation with different dosing regimens of the probiotic supplement Streptococcus salivarius K12 (Bactoblis®) in adults
IRAS ID
273843
Contact name
Paul Little
Contact email
Sponsor organisation
Research Governance Office, University of Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a prospective study for which we will recruit healthy adult participants with and without a history of sore throat/pharyngo-tonsillitis in the past 12 months. We primarily aim to recruit participants with a history of sore throat, however we will also recruit healthy individuals if we are struggling to meet our recruitment target. Our aims are to evaluate the acceptability and feasibility of two different dosing regimens of Streptococcus salivarius K12 [SsK12] (Bactoblis®) taken as oral dissolvable lozenges, and compare the prevalence of colonisation with SsK12 at various time points in order to determine how long colonisation is maintained following two different dosing regimens. A baseline whole-mouth swab will be taken, and participants will be randomly assigned (in a 1:1 ratio) to one of two groups (‘A’ or ‘B’). Group A will take two SsK12 lozenges at night on days 1, 7 and 14. Group B will take one SsK12 lozenge at night for fourteen days. Participants will be provided with instruction on how to perform a self-taken whole-mouth swab, and asked to take swabs on days 2, 7, 14, 21, and 35, and return these to the study team by post. Maintenance of colonisation will be assessed using analysis of the returned throat swabs. Participants will also be asked to complete two short online questionnaires (on day 2 and day 25 if in group A, and on day 14 and day 35 if in group B) about their compliance with the probiotic, as well as their views on the dosing regimen and other aspects of the study. These questionnaires will be accessed via an online link sent to them by email and text message. No follow-up will be undertaken after day 35.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0010
Date of REC Opinion
3 Feb 2020
REC opinion
Further Information Favourable Opinion