None listed
Conditions
Brief summary
This dual-centre, randomised, double-blind, placebo-controlled trial will evaluate the effectiveness of a probiotic formula compared to a placebo over six weeks. The trial will recruit male and female adults aged between 18 and 65 years who have been recently diagnosed with acute symptomatic streptococcal pharyngitis and/or tonsilitis. The research project will investigate the number of symptomatic days, symptom severity, antibiotic use, health-related quality of life, detection of throat Streptococcus pyogenes, changes in oral microbiota composition, inflammatory biomarkers, safety and tolerability. The outcomes of this project will provide robust evidence on a targeted probiotic approach that addresses the high clinical burden of streptococcal pharyngitis and tonsilitis, the persistent antibiotic prescribing rates in primary care, and the need for non-antibiotic adjunctive strategies through mucosal immunity support and the modification of local microbial ecosystems.
Interventions
The parallel, dual-centre, randomised, double-blind, placebo-controlled, intervention trial will examine the effect of a probiotic formula on acute symptomatic streptococcal pharyngitis and/or tonsilitis.
Participants will be randomised into either placebo or probiotic arms. The probiotic formula is registered with the Therapeutic Goods Administration (TGA) and is packaged in sachets. Each sachet contains a total of 1.25 billion CFU live probiotic cultures (Lactobacillus helveticus Rosell®-52, L
The parallel, dual-centre, randomised, double-blind, placebo-controlled, intervention trial will examine the effect of a probiotic formula on acute symptomatic streptococcal pharyngitis and/or tonsilitis. Participants will be randomised into either placebo or probiotic arms. The probiotic formula is registered with the Therapeutic Goods Administration (TGA) and is packaged in sachets. Each sachet contains a total of 1.25 billion CFU live probiotic cultures (Lactobacillus helveticus Rosell®-52, Lactobacillus rhamnosus Rosell®-11, Bifidobacterium longum Rosell®-175, and Saccharomyces boulardii CNCM I-1079) together with excipient ingredients (isomalt, xylitol and mint flavour). The placebo contains only excipient ingredients. Participants will consume one sachet daily for six weeks at night before bed. Each sachet is designed for oral administration and to be taken without food or water. Participants will allow the powder to dissolve and coat the inside of the mouth. Any antibiotics will be taken at least two hours before sachet intake. Adherence will be monitored using daily symptom and adherence diaries and returned sachet counts at the 6-week follow-up visit. Throughout the intervention period, participants will be asked to complete a daily symptom and adherence diary to capture symptom presence, severity, healthcare use, antibiotic use and study product intake. Participants will also be asked to complete a validated questionnaire once a week to assess gastrointestinal symptom severity. Participants will be asked to attend two study visits (week 0 and week 6) at the Food, Nutrition and Dietetics Laboratory at La Trobe University, Bundoora Campus. A trained researcher will conduct a clinical assessment using the Modified Centor (McIsaac) Score, a throat swab for Streptococcus pyogenes culture and a saliva sample for assessing oral microbiota composition. Early-morning venous blood samples will be drawn by a trained researcher or qualified phlebotomist. Self-reported questionnaires and diaries regarding gastrointestinal symptom severity, health-related quality of life, global improvement, food intake and physical activity will be completed. Anthropometric and body composition data will be obtained.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Recently identified in routine care as having acute symptomatic streptococcal pharyngitis and/or tonsillitis within 72 hours prior to enrolment, with eligibility confirmed by the study team based on clinical documentation and/or GP verification consistent with local clinical practice (including availability of recent throat swab/culture where applicable). • Able and willing to provide written informed consent. • Willing and able to comply with study procedures, including daily symptom reporting and attendance at baseline and Week 6 visits. • For the Melbourne site, able to read and understand English sufficiently to complete study materials.
Exclusion criteria
• Known or suspected immunodeficiency, or current use of immunosuppressive therapy. • Antibiotic use within 14 days prior to baseline enrolment. • Use of probiotics or yeast-based supplements (including Saccharomyces-supplemented products) within the past month. • Current pregnancy or breastfeeding (or planning pregnancy during the intervention period). • Known allergy or hypersensitivity to Saccharomyces boulardii, isomalt, or any product excipients. • Severe or uncontrolled chronic medical condition(s) that, in the opinion of the investigators, may confound symptom reporting, compromise participant safety, or interfere with adherence. • Current participation in another interventional clinical trial. • Any condition or circumstance that would limit the participant’s ability to complete study procedures (e.g., inability to attend visits, inability to complete diaries) or provide valid consent.
Outcome results
None listed