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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

NCT04297878 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-06

No results posted yet for this study

Summary

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

Conditions

  • Sore Throat
  • Tonsillitis
  • Pharyngitis

Interventions

DIETARY_SUPPLEMENT

probiotic supplement Streptococcus salivarius K12 (Bactoblis®)

Probiotic food supplement

Sponsors & Collaborators

  • University of Southampton

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2022-01-01
Completion
2022-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297878 on ClinicalTrials.gov