An interventional study of probiotic supplement Streptococcus salivarius K12 (Bactoblis®) in Sore Throat, Tonsillitis and Pharyngitis, sponsored by University of Southampton. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by University of Southampton · Not applicable, Interventional, and Basic science
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:
Objectives
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
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →University of Southampton is the lead sponsor of 122 studies on the registry; 18 are open to participants now.
Compared within Tonsillitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Taking two SsK12 lozenges at night on days 1, 7 and 14.
Dietary Supplement: probiotic supplement Streptococcus salivarius K12 (Bactoblis®)
One SsK12 daily at night for 14 days.
Dietary Supplement: probiotic supplement Streptococcus salivarius K12 (Bactoblis®)
Probiotic food supplement
Prevalence of colonisation with SsK12
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)
Time frame: During study involvement (days 1-35)
Acceptability of dosing regimens
To evaluate the acceptability of the two dosing regimens as measured by participant questionnaires completed on day 14 and day 35 (which include questions on a 1-5 Likert scale, as well as an opportunity to write open comments),
Time frame: During study involvement (days 1-35)
Compliance with dosing regimens
To evaluate participants compliance with the two dosing regimens. This will be self-reported by participants as part of the questionnaires completed on day 14 and day 35.
Time frame: During study involvement (days 1-35)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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