None listed
Conditions
Brief summary
In 2017-18, seasonal allergic rhinitis or hayfever affected about 4.6 million (19%) of Australians. Hayfever manifests in runny and/or blocked nose, and often itchy/sore/swollen eyes, with symptoms greatly impacting the quality of life. Rescue medication such as anti-histamines are often needed to restore function, but may trigger some other unwanted side effects. Probiotics have been shown to reduce hayfever symptoms in a number of RCTs. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Nutrition-Care Probiotic Formula ‘Seasonal Biotic’ on symptoms, quality of life, and immunological and microbial factors.
Interventions
Randomised double-blinded placebo-controlled parallel trial of 12 weeks duration investigating the efficacy of a probiotic formulation on reducing symptoms of seasonal allergic rhinitis.
The intervention will comprise of 1x 1.5g sachet of probiotics powder (active group) or placebo (control group) mixed into foods such as yoghurt, muesli, water, daily for 12 weeks.
The active powder contain Lactobacillus reuteri GL 104, Lactobacillus plantarum LPL28, Lactobacillus rhamnosus MP108, Bifidobacteriu
Randomised double-blinded placebo-controlled parallel trial of 12 weeks duration investigating the efficacy of a probiotic formulation on reducing symptoms of seasonal allergic rhinitis. The intervention will comprise of 1x 1.5g sachet of probiotics powder (active group) or placebo (control group) mixed into foods such as yoghurt, muesli, water, daily for 12 weeks. The active powder contain Lactobacillus reuteri GL 104, Lactobacillus plantarum LPL28, Lactobacillus rhamnosus MP108, Bifidobacterium animalis subsp lactis CP9 (all x 10^10 CFU/1.5g); and fructo-oligo-saccharide (prebiotic), Nutriose (prebiotic), 840mg Sorbitol. The intervention will start 1 month prior to seasonal allergy peak season (Oct) and continue 2 months during peak season (Nov-Dec 20). Compliance will be assessed by return sachet count at 4-weekly visits.
Sponsors
AProf Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Self-identified as having seasonal allergic rhinitis (hayfever) – by Rhinoconjunctivitis Quality of Life Score reflection on last season
Exclusion criteria
(1) Allergic rhinitis due to causes other than seasonal allergic rhinitis (e.g. allergy to house dust mites) (2) Pregnancy (3) Regular consumption of probiotics and not willing to stop (4a) Diagnosed with respiratory disease, including COPD, asthma, Mast Cell Activation Syndrome (MCAS) (4b) taking medication for respiratory disease including Theophylline, Anticholinergics, b2-agonists, Cromolyn (mast cell stabilizer) (5) taking regular anti-depressants (6) on antibiotics (7) Current use of immunotherapy or immunosuppressive medications and primary immunodeficiency (8) taking probiotics regularly, or not willing to stop these 2 weeks prior to the study (9) Intolerance or allergy of probiotics or sorbitol
Outcome results
None listed