Status:
UNKNOWN
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
Lead Sponsor:
University of Southampton
Conditions:
Sore Throat
Tonsillitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04297878
Start Date
March 5 2020
End Date
January 1 2022
Last Update
March 6 2020
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