title: Probiotics and Allergic Rhinitis: A Simon Two-Stage Design to Determine Effectiveness.
abstract: BACKGROUND
  Allergic rhinitis (AR) is a chronic upper respiratory disease affecting 10-30% of the population worldwide. It associated with significant economic and medical burden. Probiotics have received attention in recent years as a novel strategy to treat infectious/immune conditions, including AR. However, substantiation of these health claims by regulatory bodies has been rejected due, in part, to inadequate clinical trial design. While randomized controlled trials are considered the gold standard for assessing clinical efficacy, such trials require a priori preclinical data on effect size, which may be a reason for the conflicting results in the probiotic and AR literature. Progressive clinical trial designs, such as the Simon Two-Stage Design, are showing promise within the area of integrative and alternative medicine, particularly in relation to probiotic supplementation, to obtain empirical data for the design of clinical trials that meet regulatory requirements.
  
  
  METHODS
  This Phase II study uses a Simon Two-Stage Design to determine the response rate of patients with AR to a probiotic supplement. Patients will consume a multispecies probiotic twice daily for 8 weeks, and will attend an allergy clinic at the beginning and end of the intervention period for assessment. Symptom improvement following probiotic supplementation will be measured by the mini-Rhinoconjunctivitis Quality of Life Questionnaire. Secondary outcomes include twice-weekly symptom and medication diaries, objective determination of nasal congestion via Nasal Rhinomanometry, and change in frequency of medication usage.
  
  
  CONCLUSIONS
  This study provides an exemplar of the value of using a progressive study design in the complementary and alternative medicine setting. A Simon Two-Stage Design was adopted to investigate whether a multispecies probiotic supplement, not yet trialed in the context of AR, has promise as a therapeutic intervention and warrants the design of larger placebo-controlled studies.
authors.affiliation: 1 Menzies Health Institute Queensland, Griffith University , Southport, Australia .|2 School of Medical Science, Griffith University , Southport, Australia .
authors.forename: Annabelle M
authors.initials: AM
authors.lastname: Watts
authors.affiliation: 1 Menzies Health Institute Queensland, Griffith University , Southport, Australia .|2 School of Medical Science, Griffith University , Southport, Australia .
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: West
authors.affiliation: 3 School of Medicine, Griffith University , Southport, Australia .|4 Queensland Allergy Services Clinic , Southport, Australia .
authors.forename: Peter K
authors.initials: PK
authors.lastname: Smith
authors.affiliation: 1 Menzies Health Institute Queensland, Griffith University , Southport, Australia .
authors.forename: Allan W
authors.initials: AW
authors.lastname: Cripps
authors.affiliation: 1 Menzies Health Institute Queensland, Griffith University , Southport, Australia .|2 School of Medical Science, Griffith University , Southport, Australia .
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Cox
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017322:Clinical Trials, Phase II as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D065631:Rhinitis, Allergic / Q000628:therapy*; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Simon Two-Stage Design; allergic rhinitis; mini-Rhinoconjunctivitis Quality of Life; probiotics