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 | Unknown

• 1 other identifier: 52107.P
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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
• 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)
• To evaluate the acceptability of the two dosing regimens (as measured by participant-completed questionnaires)
• To evaluate participants compliance with the two dosing regimens (as reported by participants during completion of the questionnaires)
• NIHR Clinical Research Facility, Southampton General Hospital
• Cowley Road Medical Practice, Oxford

Conditions

Sore Throat; Tonsillitis; Pharyngitis

Outcome Measures

Primary Outcomes (3)

• 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)

  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),

  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.

  During study involvement (days 1-35)

Study Arms (2)

Group A

EXPERIMENTAL

Taking two SsK12 lozenges at night on days 1, 7 and 14.

Dietary Supplement: probiotic supplement Streptococcus salivarius K12 (Bactoblis®)

Group B

ACTIVE COMPARATOR

One SsK12 daily at night for 14 days.

Dietary Supplement: probiotic supplement Streptococcus salivarius K12 (Bactoblis®)

Interventions

probiotic supplement Streptococcus salivarius K12 (Bactoblis®) DIETARY_SUPPLEMENT

Probiotic food supplement

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years of age
• Fully conversant in the English language
• Able and willing (in the investigator's opinion) to comply with all study requirements
• Willing to take SsK12 and return throat swabs according to the study protocol
• We primarily aim to recruit participants with a history of sore throat, however we will also recruit healthy individuals with no history of sore throat if we are struggling to meet our recruitment target of 50. We are defining a 'history' of sore throat as two or more episodes of significant (as judged by the participant) sore throat/pharyngo-tonsillitis episodes in the past 12 months. However, if we are struggling to recruit, a decision may be made by the chief investigator to alter this definition to one or more episodes in the last 12 months, after consultation with the study team.

You may not qualify if:

• Involvement in a study involving the receipt of an investigational medical product within 30 days prior to, or during, the study period.
• Active symptoms of sore throat or other infection at the time of recruitment
• Presence of a chronic disease/condition (such as those affecting the oropharynx) which, in the view of the investigator, might impact on colonisation, impede analysis of the study results, put the participant at increased risk, or impact on the ability of the participant to follow the study procedures
• Participant unable to give informed consent
• Any confirmed or suspected immunosuppressive or immunodeficient state, or use of immunosuppressant medication (including oral steroids) within the last 30 days
• History of allergic disease or reactions likely to be exacerbated by any of the study treatment
• Current smokers (including e-cigarettes/vaping)
• Any other clinically significant (as determined by the investigator) abnormality on clinical examination

Sponsors & Collaborators

• University of Southampton: lead

MeSH Terms

Conditions

Pharyngitis; Tonsillitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Christopher Wilcox, MBBCh

CONTACT

07828219938; christopher.wilcox@soton.ac.uk

Merlin Willcox

CONTACT

m.l.willcox@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 6, 2020
• Study Start: March 5, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share