Background: Early phase clinical research provided initial support for the use of a multispecies probiotic supplement to improve quality of life (QoL) in adults with seasonal allergic rhinitis (AR) and reduce the use of AR symptom relieving medication. This study aimed to confirm these early phase findings in a double-blind randomized placebo-controlled trial. Methods: Individuals, aged 18-65 years, with a minimum 2-year history of AR, moderate-to-severe AR symptoms, and a positive radio-allergosorbent test to Bermuda (Couch) Grass were randomized to receive either a multispecies probiotic supplement (total colony-forming units 4 × 109/day) or placebo twice daily for 8 weeks. A mini-rhinoconjunctivitis quality of life questionnaire (mRQLQ) scale was administered at screening, days 0, 28, and 56. The proportion of participants with a >0.7 improvement in mRQLQ was the primary outcome. Participants also completed a daily symptom and medication diary during the supplementation period. Results: There were 165 participants randomized, with 142 included in the primary outcome analysis. The percentage of participants meeting the threshold for a clinically meaningful reduction in the mRQLQ from days 0 to 56 was not significantly different between groups (61% vs. 62%, p = 0.90). However, 76 participants had a clinically meaningful improvement in QoL (decrease in mRQLQ >0.7) prior to the start of supplementation (screening to day 0). Conclusion: Changes in self-reported QoL and other disease severity metrics between screening and the start of supplementation limited the ability to discern an effect of supplementation and highlight the need for adaptive clinical trial designs in allergy research. Clinical Trial Registration: The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619001319167).
Keywords: allergic rhinitis; clinical trial design; mRQLQ; probiotics.