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Trial registered on ANZCTR


Registration number
ACTRN12617001552370
Ethics application status
Approved
Date submitted
2/11/2017
Date registered
13/11/2017
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics, immune health and sleep disruption
Scientific title
Moderating the effect of sleep disruption / deprivation on gut health and the immune system with probiotics in night shift workers
Secondary ID [1] 293263 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immune health 305322 0
sleep disruption / deprivation 305393 0
Condition category
Condition code
Inflammatory and Immune System 304616 304616 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment 1 (group 1) - Lactobacillus acidophilus 10billion cfu/day. Administered orally (capsule form) once per day for 28 days.
Treatment 2 (group 2) - Bifidobacterium lactis 10billion cfu/day. Administered orally (capsule form) once per day for 28 days.

Individuals will be randomly allocated to one treatment group only. Compliance will be assessed by return of unused supplement at the completion of the intervention.
Intervention code [1] 299522 0
Treatment: Other
Intervention code [2] 299570 0
Prevention
Comparator / control treatment
Placebo - microcrystalline cellulose. Administered orally (capsule form) once per day for 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 303848 0
Immunoscore - designed for use in this study based on circulating concentrations of C-reactive protein, fibrinogen, pentraxin, E-selectin, VCAM and inflammatory cytokines (IL-6, TNF-a, IL-1B, IL-10 and IL-1RA).
Timepoint [1] 303848 0
day 15
Secondary outcome [1] 340274 0
intestinal permeability score - designed for use in this study based on a combination of circulating concentrations of lipopolysaccharide, lipopolysaccharide binding protein and intestinal fatty acid binding protein
Timepoint [1] 340274 0
day 15

Eligibility
Key inclusion criteria
engaged in a rotating work roster involving night shift work
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Has consumed probiotics, antibiotics or prebiotics in the previous 8 weeks
• Has undergone treatment with systemic corticosteroids in the previous 6 months
• uses immune-modulating medications or medications that alter sleep onset/quality
• Is pregnant or possibly pregnant
• Has current illness with a bacterial or viral infection

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)
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
30/10/2018
Actual
30/01/2018
Date of last participant enrolment
Anticipated
Actual
12/04/2019
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
90
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297893 0
Commercial sector/Industry
Name [1] 297893 0
UAS Labs
Country [1] 297893 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive, Southport, QLD, 4222
Country
Australia
Secondary sponsor category [1] 296945 0
None
Name [1] 296945 0
Address [1] 296945 0
Country [1] 296945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298942 0
Griffith University HREC
Ethics committee address [1] 298942 0
Griffith University - Bray Centre (N54)
170 Kessels Road, Nathan
QLD, 4111
Ethics committee country [1] 298942 0
Australia
Date submitted for ethics approval [1] 298942 0
05/07/2017
Approval date [1] 298942 0
14/09/2017
Ethics approval number [1] 298942 0
2017/646

Summary
Brief summary
Sleep deprivation / disruption is common across various population cohorts and is linked to poor health, decreased productivity and higher stress. Animal and human studies report a variety of changes to the immune system in response to sleep disruption/deprivation which may underpin the associated adverse health outcomes. Probiotic supplements have a strong evidence base for reducing gastrointestinal and respiratory illness and may be useful in a range of other diseases. These beneficial effects of probiotics are proposed to be via modulation of immune parameters. This study aims to investigate the effects of probiotic supplementation on alterations in indicies of immune and gut health associated with sleep disruption in an adult population. A double-blind placebo-controlled parallel group three-arm study will be undertaken in 90 adults who experience disrupted sleep due to shift work. A range of biological markers (reflecting immune and gut health) will be assessed before and after supplementation in association with sleep disruption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78730 0
Dr Amanda Cox
Address 78730 0
Griffith Health Centre (G40)
Griffith University
Parklands Drive
Southport
QLD 4222
Country 78730 0
Australia
Phone 78730 0
+61,7,56780898
Fax 78730 0
Email 78730 0
[email protected]
Contact person for public queries
Name 78731 0
Nicholas West
Address 78731 0
Griffith Health Centre (G40)
Griffith University
Parklands Drive
Southport
QLD 4222
Country 78731 0
Australia
Phone 78731 0
+61,7,56780899
Fax 78731 0
Email 78731 0
[email protected]
Contact person for scientific queries
Name 78732 0
Nicohlas West
Address 78732 0
Griffith Health Centre (G40)
Griffith University
Parklands Drive
Southport
QLD 4222
Country 78732 0
Australia
Phone 78732 0
+61,7,56780899
Fax 78732 0
Email 78732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.