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Trial registered on ANZCTR


Registration number
ACTRN12620001078943
Ethics application status
Approved
Date submitted
27/08/2020
Date registered
19/10/2020
Date last updated
23/03/2023
Date data sharing statement initially provided
19/10/2020
Date results provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Probiotics for Hayfever Trial: Effect of the NutritionCare (NC) probiotic formulation on seasonal allergic rhinitis in adults
Scientific title
Randomised double-blinded placebo-controlled parallel trial of 12 weeks duration investigating the efficacy of a probiotic formulation on symptoms of seasonal allergic rhinitis in adults
Secondary ID [1] 302161 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal allergic rhinitis 318814 0
Hayfever 319173 0
Condition category
Condition code
Inflammatory and Immune System 316824 316824 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318461 0
Prevention
Comparator / control treatment
1x 1.5g placebo powder containing fructo-oligo-saccharide, Nutriose, 840 mg Sorbitol mixed mixed into foods such as yoghurt, muesli, water, daily for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 324943 0
Composite outcome: Total Nasal and Ocular Symptom Score (TNOSS) by Questionnaire
Timepoint [1] 324943 0
1. 8 weeks and 12 weeks (primary timepoint) compared to baseline
2. daily diary during peak season (Nov-Dec 2020)
Primary outcome [2] 324944 0
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.
Timepoint [2] 324944 0
1. 8 weeks and 12 weeks (primary timepoint) compared to baseline
2. daily diary during peak season (Nov-Dec 2020)
Primary outcome [3] 324945 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Timepoint [3] 324945 0
1. 8 weeks and 12 weeks (primary timepoint) compared to baseline
2. daily diary during peak season (Nov-Dec 2020)
Secondary outcome [1] 386271 0
T-cell Th1:Th2 ratio by blood test and cytokine panel
Timepoint [1] 386271 0
8 weeks (mid-peak) post-intervention commencement compared to baseline
Secondary outcome [2] 386273 0
Stool microbial profile by multiplex PCR panel test
Timepoint [2] 386273 0
12 weeks post-intervention commencement compared to baseline
Secondary outcome [3] 386274 0
Gastrointestinal Symptom Scale (GSS) Questionnaire
Timepoint [3] 386274 0
weekly post-intervention commencement for 12 weeks

Eligibility
Key inclusion criteria
Self-identified as having seasonal allergic rhinitis (hayfever) – by Rhinoconjunctivitis Quality of Life Score reflection on last season
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Active and placebo powder will be packaged offsite in identical opaque containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher not involved in the recruitment of participants or data collection will use a computer-generated permuted block randomisation schedule to allocate patients to active or placebo groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. Continuous variables will be analysed between groups by student t-test and analysis-of-covariance (ANCOVA), and categorical variables will be analysed by Chi-square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/10/2020
Date of last participant enrolment
Anticipated
30/10/2020
Actual
30/11/2020
Date of last data collection
Anticipated
29/01/2021
Actual
29/01/2021
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 31079 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 306589 0
Commercial sector/Industry
Name [1] 306589 0
Nutrition Care
Country [1] 306589 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 307117 0
None
Name [1] 307117 0
Address [1] 307117 0
Country [1] 307117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306771 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 306771 0
Ethics committee country [1] 306771 0
Australia
Date submitted for ethics approval [1] 306771 0
11/08/2020
Approval date [1] 306771 0
08/09/2020
Ethics approval number [1] 306771 0
0074N_2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104970 0
A/Prof Karin Ried
Address 104970 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 104970 0
Australia
Phone 104970 0
+61 3 9912 9545
Fax 104970 0
Email 104970 0
karinried@niim.com.au
Contact person for public queries
Name 104971 0
Karin Ried
Address 104971 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 104971 0
Australia
Phone 104971 0
+61 3 9912 9545
Fax 104971 0
Email 104971 0
karinried@niim.com.au
Contact person for scientific queries
Name 104972 0
Karin Ried
Address 104972 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 104972 0
Australia
Phone 104972 0
+61 3 9912 9545
Fax 104972 0
Email 104972 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.