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Trial registered on ANZCTR


Registration number
ACTRN12619001319167
Ethics application status
Approved
Date submitted
10/09/2019
Date registered
26/09/2019
Date last updated
23/11/2022
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Daily probiotic supplementation and symptoms of allergic rhinitis
Scientific title
A specific probiotic intervention to improve quality of life (QoL) in allergic rhinitis (PIQAR-study): a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 299085 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 314121 0
Condition category
Condition code
Inflammatory and Immune System 312500 312500 0 0
Allergies
Respiratory 312848 312848 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily probiotic Supplementation for 8 weeks. The supplement is in the
form of a powder (2g twice daily) to be mixed with water and consumed
orally.

The supplement composition is as follows: Maize starch, Maltodextrins,
Bacterial strains (Bifidobacterium bifidum W23, Lactobacillus acidophilus
W55, Lactobacillus casei W56, Lactobacillus salivarius W57 and
Lactococcus lactis W58 - >1x10^9 cfu/g) Vitamin B2 and Biotin.

Compliance will be encouraged with a daily checklist and monitored by
supplementation return at the end of the intervention period.
Intervention code [1] 315354 0
Treatment: Other
Comparator / control treatment
Placebo -

Daily placebo Supplementation for 8 weeks. The supplement is in the
form of a powder (2g twice daily) to be mixed with water and consumed
orally.

The placebo supplement composition is as follows: Maize starch, Maltodextrin, and Colour (E102).
Control group
Placebo

Outcomes
Primary outcome [1] 321134 0
Quality of life score associated with Allergic rhinitis. This will be assessed through completion and analysis of Rhinitis Quality of Life Questionnaires (RQLQ) and Allergic rhinitis symptoms on a Visual Analogue Scale and a composite score calculated.
Timepoint [1] 321134 0
Intervention period is 8 weeks. Primary endpoints will be determined before supplementation (week 0) and at the end of week 8.
Secondary outcome [1] 374101 0
Self reported use (based on daily symptom and medication diary) of medications to treat rhinitis symptoms..
Timepoint [1] 374101 0
Daily for 8 weeks.

Eligibility
Key inclusion criteria
• Be Male or female;
• Be aged between 18-65 years;
• Have more than 2 years history of moderate to severe persistent allergic rhinitis;
• Have moderate to severe allergic rhinitis as rated by the Allergic Rhinitis and its Impact
on Asthma (ARIA) criteria
• Have a positive radio-allergosorbent test (RAST) to Bermuda (couch) grass.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have non-allergic rhinitis
• Have a negative RAST to Bermuda grass
• Report consumption of probiotics or prebiotics in the previous 12 weeks;
• Report treatment with systemic corticosteroids in the previous 6 months;
• Have a history of respiratory diseases such as nasal polyposis and COPD ;
• Have a current respiratory viral infectious disease (common cold);
• Report current pregnancy or attempting to become pregnant;
• Report use of medications which effect salivary flow and components such as systemic
corticosteroids, diuretics and antidepressants;
• Allergic, sensitive or intolerant to (one of) the ingredients of the study product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
22/10/2019
Date of last participant enrolment
Anticipated
Actual
21/01/2021
Date of last data collection
Anticipated
Actual
19/02/2021
Sample size
Target
165
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 303622 0
Commercial sector/Industry
Name [1] 303622 0
Winclove Holding b.v.
Country [1] 303622 0
Netherlands
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus
Parklands Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 304007 0
None
Name [1] 304007 0
Address [1] 304007 0
Country [1] 304007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304148 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 304148 0
Ethics committee country [1] 304148 0
Australia
Date submitted for ethics approval [1] 304148 0
Approval date [1] 304148 0
30/07/2019
Ethics approval number [1] 304148 0
2019/474

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

Contacts
Principal investigator
Name 95962 0
Dr Amanda Cox
Address 95962 0
Griffith University
G40_9.17, Parklands Drive, Southport, QLD, 4215
Country 95962 0
Australia
Phone 95962 0
+61 7 56780898
Fax 95962 0
Email 95962 0
[email protected]
Contact person for public queries
Name 95963 0
Nicholas West
Address 95963 0
Griffith University
G40_9.17, Parklands Drive, Southport, QLD, 4215
Country 95963 0
Australia
Phone 95963 0
+61 7 56780899
Fax 95963 0
Email 95963 0
[email protected]
Contact person for scientific queries
Name 95964 0
Nicholas West
Address 95964 0
Griffith University
G40_9.17, Parklands Drive, Southport, QLD, 4215
Country 95964 0
Australia
Phone 95964 0
+61 7 56780899
Fax 95964 0
Email 95964 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseAssessment of a Multispecies Probiotic Supplement for Relief of Seasonal Allergic Rhinitis: A Randomized Double-Blind Placebo-Controlled Trial.2023https://dx.doi.org/10.1089/jicm.2022.0734
N.B. These documents automatically identified may not have been verified by the study sponsor.