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Trial registered on ANZCTR


Registration number
ACTRN12617000611325
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
28/04/2017
Date last updated
30/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the effects of probiotics on the immune system.
Scientific title
Examining the effects of probiotics on the immune system in healthy adults.
Secondary ID [1] 291286 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ProImmune
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Human immune system 302241 0
Condition category
Condition code
Inflammatory and Immune System 301837 301837 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention, dose and duration: The effect of probiotics on immune regulatory function, Six commercially available probiotics will be examined (one probiotic per study group):

Eczema shield (Ethical Nutrients) – 2 capsules per day (2x10^10 cfu/day, Lactobacillus rhamnosus) for 14 days
Travel bug (Ethical Nutrients) – 2 capsules per day (1 x 10^10 cfu/day, Saccharomyces boulardii) for 14 days
Mutaflor (Natural Therapy Imports) - 2 capsules twice a day (1 x 10^10 cfu twice a day, E. coli Nissle 1917 ) for 14 days
Bifidobacteria lactis – 2 capsules per day (1 x 10^10 cfu/day) for 14 days
Streptococcus thermophilus – dry powder 100 billion cfu per g (2 x 10^10 cfu per day, i.e. 200mg per day) for 14 days
Bifidobacteria breve – dry powder 100 billion cfu per g (2 x 10^10 cfu per day, i.e. 200mg per day) for 14 days

Mode of adminstration: Oral

Personalised intervention: No
Intervention adherence: Compliance will be monitored by capsule counts and by completion of a daily diary of doses taken. Diaries will be reviewed at Day 8 and Day 15 and missed doses recorded. Non-compliance will be defined as missing more than 1 dose. The study nurse will assess compliance.
Intervention code [1] 297306 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301258 0
Number of T cells, assessed by flow cytometry labeling
Timepoint [1] 301258 0
Day 8
Primary outcome [2] 301893 0
Number of Treg cells, assessed by flow cytometry labeling
Timepoint [2] 301893 0
Day 8
Primary outcome [3] 301894 0
Number of dendritic cells, assessed by flow cytometry labeling
Timepoint [3] 301894 0
Day 8
Secondary outcome [1] 332116 0
Number of T cells, assessed by flow cytometry labeling
Timepoint [1] 332116 0
Day 15
Secondary outcome [2] 332117 0
Functional proliferation response in vitro, assessed by CFSE-based proliferation assay
Timepoint [2] 332117 0
Day 8 and Day 15.
Secondary outcome [3] 334224 0
Number of Treg cells, assessed by flow cytometry labeling
Timepoint [3] 334224 0
Day 15
Secondary outcome [4] 334225 0
Number of dendritic cells, assessed by flow cytometry labeling
Timepoint [4] 334225 0
Day 15

Eligibility
Key inclusion criteria
Healthy adults aged between 18-60 years.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Already taking probiotics
* Inflammatory intestinal conditions, indwelling catheter, gastrostomy, or other condition associated with increased risk of probiotic associated sepsis
* Proven or suspected immunodeficiency
* Pregnancy
* Recent intake of antibiotics in the preceding 1 week

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is an open label study and participants will not be randomised. Participants will be assigned to a probiotic group sequentially in the order they are consented. Allocation will not be stratified and each probiotic group will contain equal numbers of participants (n=20).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION
The study sample for each probiotic tested will be n=20. This sample size is expected to provide sufficient power to detect biologically significant pre-post changes in the primary outcome (Boyle et al CEA 2008;38:1882).

No comparisons will be made between probiotic groups.

STATISTICAL ANALYSIS PLAN
Continuous data will be presented as arithmetic means +/- 1 SD, or medians with inter-quartile ranges. Categorical data will be analysed using Chi2 test or Fisher’s exact test. Data will be displayed using histograms to identify whether outcomes have a normal or non-normal distribution.

As the primary objective is to compare post-treatment immune measures with pre-treatment measures within each group of participants receiving a single probiotic species, paired statistical tests will be employed. Normally distributed outcomes will be analysed using the paired t-test, and non-normally distributed ones using Wilcoxon signed rank test and Sign test. As a sensitivity analysis, skewed data will be log10 transformed and analysed using the same parametric tests employed for the normally distributed outcomes.

P value <0.05 will be considered statistically significant, with due caution in interpreting the results of multiple comparisons. Analysis will include those samples where paired data is available from both pre- and post-treatment time points. No comparisons between probiotic groups will be made.

POPULATION TO BE ANALYSED
The analysis will be performed on all data where results are available for both pre- and post-treatment time points.

HANDLING OF MISSING DATA
Participants who withdraw or are withdrawn from the study prior to study completion will not be included in analyses. Participants with missing data (no data at pre- or post-treatment time point) will be excluded from analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
6/06/2017
Date of last data collection
Anticipated
15/09/2017
Actual
14/09/2017
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7566 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 15456 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295750 0
Commercial sector/Industry
Name [1] 295750 0
ProTA
Country [1] 295750 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
50 Flemington Road
Parkville VIC 3205
Country
Australia
Secondary sponsor category [1] 294594 0
Individual
Name [1] 294594 0
Prof Mimi Tang
Address [1] 294594 0
Murdoch Childrens Research Institute
50 Flemington Road
Parkville VIC 3205
Country [1] 294594 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297051 0
The Royal Children's Hospital Human Research Ethics Committee (RCH HREC)
Ethics committee address [1] 297051 0
Ethics committee country [1] 297051 0
Australia
Date submitted for ethics approval [1] 297051 0
10/01/2017
Approval date [1] 297051 0
01/02/2017
Ethics approval number [1] 297051 0
37002

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

Contacts
Principal investigator
Name 72814 0
Prof Mimi Tang
Address 72814 0
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3205
Country 72814 0
Australia
Phone 72814 0
+61 3 9345 5911
Fax 72814 0
Email 72814 0
mimi.tang@rch.org.au
Contact person for public queries
Name 72815 0
Mimi Tang
Address 72815 0
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3205
Country 72815 0
Australia
Phone 72815 0
+61 3 9345 5911
Fax 72815 0
Email 72815 0
mimi.tang@rch.org.au
Contact person for scientific queries
Name 72816 0
Mimi Tang
Address 72816 0
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3205
Country 72816 0
Australia
Phone 72816 0
+61 3 9345 5911
Fax 72816 0
Email 72816 0
mimi.tang@rch.org.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
No additional documents have been identified.