Evidence map›Paper›PMID 42744363›Full record

Trial reportBMJ open2026

BLIS study: a feasibility randomised controlled trial assessing compliance, acceptability and colonisation with different dosing regimens of the probiotic supplement

Christopher R Wilcox, David W Cleary, Maclyn Augustine, Rebecca Anderson, Nick Francis, Mark Lown, Michael Moore, Paul Little, Stuart C Clarke, Merlin Willcox

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04297878 (The BLIS Study), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04297878 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversity of SouthamptonRan2020 to 2022Enrolled50ConditionsSore Throat, Tonsillitis, PharyngitisArmsprobiotic supplement Streptococcus salivarius K12 (Bactoblis®)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Christopher R WilcoxPrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.
David W ClearyDepartment of Microbes, Infections, and Microbiomes, College of Medicine and Health & Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.
Maclyn AugustinePrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.ORCID http://orcid.org/0000-0003-3848-6854
Rebecca AndersonUniversity of Southampton Faculty of Medicine Health and Life Sciences, Southampton, UK.
Nick FrancisPrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.ORCID http://orcid.org/0000-0001-8939-7312
Mark LownPrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.ORCID http://orcid.org/0000-0001-8309-568X
Michael MoorePrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.ORCID http://orcid.org/0000-0002-5127-4509
Paul LittlePrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK.ORCID http://orcid.org/0000-0003-3664-1873
Stuart C ClarkeNIHR Southampton Biomedical Research Centre, Southampton, UK.
Merlin WillcoxPrimary Care Research Centre, University of Southampton School of Primary Care Population Sciences and Medical Education, Southampton, UK m.l.willcox@soton.ac.uk.ORCID http://orcid.org/0000-0002-5227-3444

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectives

designA randomised, non-blinded feasibility trial.

settingPrimary care in the south of England.

participantsAdults with ≥2 episodes of sore throat within the 3 years before recruitment.

interventionsParticipants were randomised to take SsK12 lozenges once weekly or daily over 14 days.

main outcome measuresThe primary outcome was the prevalence and duration of colonisation with SsK12. This was determined by real-time PCR conducted on self-taken whole-mouth swabs provided by participants at baseline and on days 2, 7, 14, 21 and 35. Secondary outcomes were the compliance and acceptability of the two SsK12 dosing regimens, based on questionnaire data.

results53 participants were recruited (26 randomised to weekly and 27 to daily dosing) between 26 April and 5 December 2023. All swabs were returned by 65.4% (17/26) and 70.4% (19/27) of the weekly and daily groups respectively. Swabs at all timepoints from participants with PCR positives observed at baseline (two and four from the weekly and daily group, respectively) were excluded. Therefore, swabs from 23 participants in the weekly and 22 in the daily group did not have evidence of baseline colonisation and were included in the microbiology analysis. SsK12 colonisation was found in 59.1% (13/22, 95% CI 38.6% to 79.6%) of samples in both groups on day 2; in 13.6% (3/22, 95% CI 0.0% to 28.0%) and 85.7% (18/21, 95% CI 70.8% to 100.0%) of the weekly and daily groups, respectively, on day 7; in 19.1% (4/21, 95% CI 2.3% to 35.8%) and 59.1% (13/22, 95% CI 38.6% to 79.6%), respectively, on day 14; and in only one participant (weekly group) on days 21 and 35. The dosing regimen was reported as easy to follow by 85.0% (17/20, 95% CI 69.4% to 100.0%) of the weekly and 96.2% (25/26, 95% CI 88.8% to 100.0%) of the daily dosing groups.

conclusionsSsK12 colonisation was more prevalent with daily dosing; however, colonisation was not maintained when dosing stopped. Both dosing regimens were acceptable to participants. These findings support the use of daily dosing in a future trial to evaluate the efficacy of SsK12 in preventing recurrence of sore throat/tonsillitis. TRIAL REGISTRATION NUMBER: NCT04297878.

Indexed as

Patient CompliancePharyngitisProbioticsStreptococcus salivariusAdultEnglandFeasibility StudiesFemaleHumansMaleMiddle AgedStreptococcal InfectionsClinical TrialFeasibility StudiesGeneral PracticeINFECTIOUS DISEASESMICROBIOLOGYOTOLARYNGOLOGY

Identifiers

PMID42744363
PMCPMC13583812

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.