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Trial registered on ANZCTR


Registration number
ACTRN12615001103550
Ethics application status
Approved
Date submitted
23/09/2015
Date registered
20/10/2015
Date last updated
28/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of probiotic supplementation on symptoms and quality of life of individuals suffering Allergic rhinitis
Scientific title
Does treatment with probiotics improve the symptoms and quality of life in individuals suffering Allergic rhinitis.
Secondary ID [1] 287527 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 296292 0
Condition category
Condition code
Inflammatory and Immune System 296568 296568 0 0
Allergies
Respiratory 296643 296643 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] 292920 0
Treatment: Other
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296186 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] 296186 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] 317732 0
Change in degree of nasal congestion. This will be measured with through Nasal Rhinomanometry.
Timepoint [1] 317732 0
Endpoints will be determined before supplementation (week 0) and at the end of the supplementation period (week 8).
Secondary outcome [2] 317733 0
Self-reported change in perceived resilience via the 10-item Connor Davidson Resilience Scale (CD-RISK).
Timepoint [2] 317733 0
Endpoints will be determined before supplementation (week 0) and at the end of the supplementation period (week 8)

Eligibility
Key inclusion criteria
For inclusion in the study participants are required to be aged between 17-60, have a history of moderate to severe persistent Allergic rhinitis, test positive to both a skin prick test and a radio-allergosorbent test to Bermuda (couch) grass.
Minimum age
17 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they:
Suffer from non-allergic rhinitis;
Do not test positive for on the skin prick test and radio-allergosorbent test to Bermuda grass;
Have undergone treatment with systemic corticosteroids in the previous 6 months;
Have a history of respiratory or immune diseases;
Use of anti-inflammatory or immune modulating medications;
Consumption of probiotics or prebiotic supplements in the previous 12 weeks;
Use of Antibiotics within the last 30 days;
Are pregnant or intending to become pregnant during the trial period;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A repeated measures within group analysis will be undertaken to ascertain the mean effect and 95% confidence intervals.
Sample size (of n=50) was determined based on a 30% or greater reduction in rhinitis quality of life scores with a confidence interval of 15-45% (equivalent to 80% power).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/09/2015
Date of last participant enrolment
Anticipated
Actual
22/01/2016
Date of last data collection
Anticipated
Actual
24/03/2016
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292096 0
Commercial sector/Industry
Name [1] 292096 0
Winclove Holding b.v.
Country [1] 292096 0
Netherlands
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus
Parklands Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 290775 0
None
Name [1] 290775 0
Address [1] 290775 0
Country [1] 290775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293583 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293583 0
Ethics committee country [1] 293583 0
Australia
Date submitted for ethics approval [1] 293583 0
Approval date [1] 293583 0
21/08/2015
Ethics approval number [1] 293583 0
AHS/45/15/HREC

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

Contacts
Principal investigator
Name 60550 0
Dr Amanda Cox
Address 60550 0
Griffith University Gold Coast Campus G40_9.17 Parklands Drive Southport QLD 4222. Australia
Country 60550 0
Australia
Phone 60550 0
+61 07 56780898
Fax 60550 0
Email 60550 0
a.cox@griffith.edu.au
Contact person for public queries
Name 60551 0
Nicholas West
Address 60551 0
Griffith University Gold Coast Campus G40_9.17 Parklands Drive Southport QLD 4222. Australia
Country 60551 0
Australia
Phone 60551 0
+61 07 56780899
Fax 60551 0
Email 60551 0
n.west@griffith.edu.au
Contact person for scientific queries
Name 60552 0
Nicholas West
Address 60552 0
Griffith University Gold Coast Campus G40_9.17 Parklands Drive Southport QLD 4222. Australia
Country 60552 0
Australia
Phone 60552 0
+61 07 56780899
Fax 60552 0
Email 60552 0
n.west@griffith.edu.au

No information has been provided regarding IPD availability


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
EmbaseProbiotics and allergic rhinitis: A simon two-stage design to determine effectiveness.2016https://dx.doi.org/10.1089/acm.2016.0115
EmbaseA specifically designed multispecies probiotic supplement relieves seasonal allergic rhinitis symptoms.2018https://dx.doi.org/10.1089/acm.2017.0342
N.B. These documents automatically identified may not have been verified by the study sponsor.