Trial Review

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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
Date results information initially provided
23/11/2022
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
Griffith University, Gold Coast Campus
Parklands Drive,
Southport, QLD, 4215
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
The symptoms of Allergic rhinitis, such as nasal congestion and itching, are a burden for an estimated 3.2 million Australians and its prevalence is increasing. There is growing evidence to suggest that probiotic supplementation elicits beneficial health effects on the host through modulation of the immune system and thereby can improve symptoms associated with Allergic rhinitis. The aim of this research is to examine the effect of probiotic supplementation on symptoms and quality of life in individuals suffering from Allergic rhinitis.
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
Dr 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
Dr 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.