Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000480987p
Ethics application status
Not yet submitted
Date submitted
13/04/2020
Date registered
16/04/2020
Date last updated
16/04/2020
Date data sharing statement initially provided
16/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Stress-reduction Using Probiotics to Promote Ongoing Resilience Throughout COVID-19 for Healthcare Workers (SUPPORT COVID-19 Healthcare Workers)
Scientific title
Stress-reduction Using Probiotics to Promote Ongoing Resilience Throughout COVID-19 for Healthcare Workers: A randomised placebo-controlled trial
Secondary ID [1] 300993 0
None
Universal Trial Number (UTN)
Trial acronym
SUPPORT COVID-19 Healthcare Workers
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Stress 317035 0
COVID19 317079 0
Condition category
Condition code
Mental Health 315197 315197 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 315247 315247 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomly assigned to the intervention group will receive capsules containing the probiotic Lactobacillus rhamnosus HN001 (6X109 colony forming units).

Participants will be instructed to take one capsule a day for a period of 12 weeks.

Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phase.
Intervention code [1] 317317 0
Prevention
Comparator / control treatment
Approximately half the participants will be assigned to receive placebo capsules containing corn-derived maltodextrin. These capsules will be identical in taste, smell and appearance to the intervention capsules.
Participants will be instructed to take one capsule per day for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 323455 0
Scores on the Perceived Stress Scale. The PSS is a widely used measure of the appraisal of how stressful events over the previous month are. Scores range from 0 to 40 with higher scores representing higher levels of stress.
Timepoint [1] 323455 0
Perceived Stress Scale scores will be measured at baseline and following a 12 week intervention period, with the primary time point of interest being scores post the 12 week intervention period.
Secondary outcome [1] 382003 0
The State Trait Anxiety Inventory 6 item version (STAI6) is a short 6 item scale validated as an anxiety screening questionnaire based on the longer State Trait Anxiety Inventory.
Timepoint [1] 382003 0
Post intervention data collection
Secondary outcome [2] 382052 0
The World Health Organisation wellbeing index (WHO-5) is a five item, positively worded measure of psychological well-being score ranging from 0 to 25. Higher scores represent better well-being. Scores of 13 or lower indicate low levels of psychological well-being.
Timepoint [2] 382052 0
Post intervention data collection
Secondary outcome [3] 382053 0
Symptoms of respiratory tract Infections will be measured by recording how many days during the previous week a participant experienced symptoms of a respiratory tract infection. This will be recorded in number of days (0-7) each week.
Timepoint [3] 382053 0
Post intervention data collection

Eligibility
Key inclusion criteria
Eligible participants are nurses working in a clinical area.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Already taking probiotic supplements
2. Taking immune suppressant medication

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)
This is a double-blind placebo controlled trial.
Neither the participants nor the researchers will know which group (intervention or placebo) participants have been assigned to.

The randomisation schedule will be arranged and held by Fonterra Cooperative New Zealand who are supplying the capsules for this study. Fonterra will provide capsules in numbered bottles and hold the randomisation schedule at their site (different from the the research site) throughout the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention to treat analysis will be conducted in SAS 9.4 using generalised linear regression for continuous stress scores, and for anxiety and psychological wellbeing scores. Logistic regression will be used to analyse the number of days of URT infection between the two groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
16/07/2020
Actual
Date of last data collection
Anticipated
18/10/2020
Actual
Sample size
Target
507
Accrual to date
Final
Recruitment outside Australia
Country [1] 22484 0
New Zealand
State/province [1] 22484 0

Funding & Sponsors
Funding source category [1] 305438 0
Self funded/Unfunded
Name [1] 305438 0
Country [1] 305438 0
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 305836 0
None
Name [1] 305836 0
Not Applicable
Address [1] 305836 0
Not Applicable
Country [1] 305836 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305757 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 305757 0
Auckland Health Research Ethics Committee
Level 3, 49 Symonds Street, Auckland 1010
Private Bag 92019, Auckland 1142, New Zealand
Ethics committee country [1] 305757 0
New Zealand
Date submitted for ethics approval [1] 305757 0
20/04/2020
Approval date [1] 305757 0
Ethics approval number [1] 305757 0

Summary
Brief summary
Healthcare workers are experiencing additional stress due to the COVID19 pandemic.
The primary objective of this study is to determine if giving essential healthcare workers a probiotic supplement during the COVID19 pandemic can reduce their stress. The study will recruit 507 nurses working in clinical environments. Participants will complete questionnaires about stress, anxiety, and depression before being randomly assigned to receive capsules containing either the probiotic Lactobacillus rhamnosus HN001 or a placebo and asked to take one a day for 12 weeks. At the end of 12 weeks participants will be asked to complete the psychological stress questions again. A secondary outcome of interest is the number of days of cold and flu symptoms between the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101490 0
Dr Rebecca Slykerman
Address 101490 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 101490 0
New Zealand
Phone 101490 0
+64 9 923 1132
Fax 101490 0
Email 101490 0
[email protected]
Contact person for public queries
Name 101491 0
Rebecca Slykerman
Address 101491 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 101491 0
New Zealand
Phone 101491 0
+64 9 923 1132
Fax 101491 0
Email 101491 0
[email protected]
Contact person for scientific queries
Name 101492 0
Rebecca Slykerman
Address 101492 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 101492 0
New Zealand
Phone 101492 0
+64 9 923 1132
Fax 101492 0
Email 101492 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
In line with ethical guidelines only the research team will have access to individual level participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7605Study protocol  [email protected] 379608-(Uploaded-13-04-2020-13-00-08)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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