None listed
Conditions
Brief summary
We would like to conduct this scientific study to determine whether we could colonise the nasopharynx (back of the nose) with a "good bacteria" that has the ability to stop the growth of "bad bacteria that causes middle ear infection (via bacteriocin like inhibitory substance). In doing so, we would like to test it's ability of altering nasopharyngeal presence of known pathogens that causes otitis media (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis). To investigate this feasibility we will recruit healthy adult volunteers to be given a short course of oral antibiotics followed by a short prescribed course of nasal or oral probiotics produced by BLIS technologies containing S. Salivarius (BLIS producing organism). The recruited individual will have their nasopharynx cultured prior to probiotics to provide baseline composition. After the prescribed course of antibiotics and followed by probiotics, participants will have a "washout" time period, following this we will then culture the nasopharynx. The primary outcome will be look at the rate of colonisation by S. salivarius, and the secondary rate will be to look at the alteration in the composition of the nasopharynx of the pre determined oto-pathogens.
Interventions
Enrolled participants will be given a course of oral antibiotics. An individual without penicillin allergy will be given a course of 500mg of amoxicillin twice daily for 5 days. Those with penicillin allergy will be given a course of erythromycin 800mg twice daily also for 5 days.
Participants will then be given the probiotics (BLIS K12) containing Streptococcus salivarius via the pre-determined route, whether trans-nasal drops or chewable lozenge. The determination of the route will be altern
Enrolled participants will be given a course of oral antibiotics. An individual without penicillin allergy will be given a course of 500mg of amoxicillin twice daily for 5 days. Those with penicillin allergy will be given a course of erythromycin 800mg twice daily also for 5 days. Participants will then be given the probiotics (BLIS K12) containing Streptococcus salivarius via the pre-determined route, whether trans-nasal drops or chewable lozenge. The determination of the route will be alternated on enrolment. The course of probiotics will commence 1 day after the antibiotics and be given for a 2 weeks course. Both formulation (lozenge and nasal drops) of the BLIS K12 will be supplied by BLIS technologies (Dunedin) in the pre-approved commercially available form. The group with nasal drop will receive a solution prepared in sterile conditions by BLIS technologies, from freeze-dried skim-milk containing S. salivarius and suspended in sesame oil and tween 80. Both forms of probiotics will come with instruction of use and storage information. Both formulation will have 2.5 billion colony forming unit (CFU) per dose, taken twice daily. Adherence to the regime will be monitored at the second follow up visit with the left over lozenge counted for the oral formulation and the nasal drop weighed.
Sponsors
BLIS technologies
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All healthy adults volunteers.
Exclusion criteria
Concurrent or recent (<12 weeks) use of any form of antibiotics, known allergy to BLIS products, active infection of the upper respiratory tract (including paranasal sinuses).
Outcome results
None listed