The Probiotics for Hayfever Trial: Effect of the NutritionCare (NC) probiotic formulation on seasonal allergic rhinitis in adults

Not Applicable

Completed

• Conditions: Seasonal allergic rhinitis; Hayfever; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12620001078943
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-19
• Study Completion: 2021-01-29
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome: Total Nasal and Ocular Symptom Score (TNOSS) by Questionnaire[1. 8 weeks and 12 weeks (primary timepoint) compared to baseline<br>2. daily diary during peak season (Nov-Dec 2020)];Composite score: TNOSS Symptom Score & Rescue Medication Score by Questionnaire, as described in Pfarr et al. Allergy 69.7 (2014): 854-867. The composite score consists of the symptom score consisting of 8 symptoms on a 6-point Likert scale in combination with the rescue medication score consisting of 3 main types of rescue medication on a 3 Likert-scale.[1. 8 weeks and 12 weeks (primary timepoint) compared to baseline<br>2. daily diary during peak season (Nov-Dec 2020)];Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)[1. 8 weeks and 12 weeks (primary timepoint) compared to baseline<br>2. daily diary during peak season (Nov-Dec 2020)]

Secondary Outcome Measures

Name	Time	Method
T-cell Th1:Th2 ratio by blood test and cytokine panel[8 weeks (mid-peak) post-intervention commencement compared to baseline ];Stool microbial profile by multiplex PCR panel test[12 weeks post-intervention commencement compared to baseline ];Gastrointestinal Symptom Scale (GSS) Questionnaire[weekly post-intervention commencement for 12 weeks]