Pharyngitis Clinical Trial
Official title:
The BLIS Study: a Feasibility Study Assessing Compliance, Acceptability and Colonisation With Different Dosing Regimens of the Probiotic Supplement Streptococcus Salivarius K12 (Bactoblis®) in Adults
Short title The BLIS 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
Population 50 human adults with or without a history of significant sore throat 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.
Interventions
Two groups will receive two different dosing regimens of Ssk12 probiotic oral lozenges:
- Group A: two SsK12 lozenges at night on days 1, 7 and 14.
- Group B: one SsK12 daily at night for 14 days. Throat swabs will be taken at baseline,
and days 2, 7, 14, 21, 35
Objectives
1. To evaluate the prevalence of colonisation with SsK12 (as determined by real-time
Polymerase Chain Reaction [PCR] and culture of participant-take whole-mouth swabs at
pre-determined time points during the study)
2. To evaluate the acceptability of the two dosing regimens (as measured by
participant-completed questionnaires)
3. To evaluate participants compliance with the two dosing regimens (as reported by
participants during completion of the questionnaires)
Rationale SsK12 probiotic supplements are recognised as safe food ingredients, and there is
preliminary evidence to support their use as prophylactic therapy to prevent episodes of
pharyngo-tonsillitis. Existing clinical trials have all given SsK12 once daily over a period
of months. It remains unclear whether a once-daily dosing regimen is needed in order to
establish and maintain colonisation.
Study design This is a prospective study for which we will recruit healthy adult participants
with and without a history of sore throat/ pharyngo-tonsillitis. We will evaluate [1] the
acceptability and feasibility of two different dosing regimens of SsK12 supplements (taken as
oral dissolvable lozenges), and [2] compare the prevalence of colonisation with SsK12 at
various time points in order to determine how long colonisation is maintained following a
loading dose. 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 SsK12 at night for 14 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. They will also be asked to complete two short online questionnaires (on day 14
and day 35) about their compliance with the probiotic, as well as their views on the dosing
regimen and other aspects of the study. Maintenance of colonisation will be assessed using
analysis of the returned throat swabs. No follow-up will be undertaken after day 35.
Sample size Total = 50 (25 in group A, and 25 in group B)
Setting
1. NIHR Clinical Research Facility, Southampton General Hospital
2. Cowley Road Medical Practice, Oxford
n/a
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