Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000275965
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
3/03/2020
Date last updated
4/02/2022
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics for Reduction of Exam Stress in Students Study
Scientific title
Investigating the effect of probiotic supplementation to reduce exam stress in university students.: A randomised, double-blind, placebo controlled trial
Secondary ID [1] 300598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 316348 0
Condition category
Condition code
Mental Health 314604 314604 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Students will take one capsule a day from the time that they are enrolled in the study and supplied with the capsules until the day of their exam. The intervention period will be between 8-12 weeks but a minimum of 8 weeks.

Capsules containing the probiotic Lactobacillus rhamnosus HN001 (6×109 colony forming units) manufactured to pharmaceutical grade will be supplied by Fonterra. Placebo capsules identical in appearance and smell to the probiotic contain corn-derived matodextrin. Both probiotic and placebo capsules are lactose free and gluten free. The probiotic L. rhamnosus HN001 (6 X 109 cfu) has been safely used in previous studies conducted in New Zealand.

Adherence will be assessed by supplying participants with more capsules than they need for the trial period. Participants will be asked to report the number of capsules they have reamining when they complete post-intervention questions at the end of the trial period. A text reminder will be sent to participants during the trial period reminding them to take the capsules.
Intervention code [1] 316907 0
Prevention
Intervention code [2] 316981 0
Treatment: Other
Comparator / control treatment
Identical to intervention group but with placebo capsules containing maltodextran
Control group
Placebo

Outcomes
Primary outcome [1] 322937 0
A change in perceived stress scale scores between the probiotic supplemented group and placebo group. Stress will be measured using the Perceived Stress Scale (PSS) by Cohen et al.
Timepoint [1] 322937 0
Assessed at 12 weeks post-baseline.
Secondary outcome [1] 380295 0
Change in anxiety levels using the State Trait Anxiety Inventory 6 item version (STAI6) scale.
Timepoint [1] 380295 0
Assessed at 12 weeks post-baseline.

Eligibility
Key inclusion criteria
The New Zealand university system operates on two semesters per year with examinations for a paper being held at the end of a semester. The PRESS Study will recruit 815 students enrolled in either the POPHEALTH 111 paper or the PSYCH 108 & 109 papers taken by first year students.
Minimum age
17 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are three exclusion criteria for the study. Participants will be excluded if they are:
- Currently taking a regular probiotic supplement
- Currently taking immunosuppressant’s e.g. chemotherapy
- Currently involved in another trial

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)
Numbered containers. Randomisation is undertaken by Fonterra who will supply capsules for this study. neither the researchers nor the participants will know who has been radndomised to probiotic or placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fonterra undertake the randomisation of participants and will hold the randomisation schedule. Participants will be sequentially assigned a participant number and will recieve the bottle of capsules with that participant number.
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Generalised linear regression and logistic regression models.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/03/2020
Actual
11/03/2020
Date of last participant enrolment
Anticipated
27/03/2020
Actual
13/04/2020
Date of last data collection
Anticipated
29/06/2020
Actual
15/06/2020
Sample size
Target
815
Accrual to date
Final
483
Recruitment outside Australia
Country [1] 22365 0
New Zealand
State/province [1] 22365 0
Auckland

Funding & Sponsors
Funding source category [1] 305021 0
Commercial sector/Industry
Name [1] 305021 0
Fonterra Co-operative Ltd.
Country [1] 305021 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 305377 0
None
Name [1] 305377 0
Address [1] 305377 0
Country [1] 305377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305416 0
University of Auckland Human Participants Ethics Commitee
Ethics committee address [1] 305416 0
Ethics committee country [1] 305416 0
New Zealand
Date submitted for ethics approval [1] 305416 0
Approval date [1] 305416 0
09/12/2019
Ethics approval number [1] 305416 0
023964

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

Contacts
Principal investigator
Name 100306 0
Dr Rebecca Slykerman
Address 100306 0
Department of Psychological Medicine
The University of Auckland
Room 3033
Building 507
22-30 Park Avenue
Grafton 1023
Country 100306 0
New Zealand
Phone 100306 0
+64 99231132
Fax 100306 0
Email 100306 0
[email protected]
Contact person for public queries
Name 100307 0
Rebecca Slykerman
Address 100307 0
Department of Psychological Medicine
The University of Auckland
Room 3033
Building 507
22-30 Park Avenue
Grafton 1023
Country 100307 0
New Zealand
Phone 100307 0
+64 99231132
Fax 100307 0
Email 100307 0
[email protected]
Contact person for scientific queries
Name 100308 0
Rebecca Slykerman
Address 100308 0
Department of Psychological Medicine
The University of Auckland
Room 3033
Building 507
22-30 Park Avenue
Grafton 1023
Country 100308 0
New Zealand
Phone 100308 0
+64 99231132
Fax 100308 0
Email 100308 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
Ethical approval not given for individual level data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6980Study protocol    379312-(Uploaded-21-01-2022-15-28-56)-Study-related document.docx
6981Ethical approval    379312-(Uploaded-19-02-2020-13-23-48)-Study-related document.pdf
6982Informed consent form    379312-(Uploaded-19-02-2020-13-01-59)-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
SourceTitleYear of PublicationDOI
EmbaseProbiotics for Reduction of Examination Stress in Students (PRESS) study: A randomized, double-blind, placebo-controlled trial of the probiotic Lacticaseibacillus rhamnosus HN001.2022https://dx.doi.org/10.1371/journal.pone.0267778
N.B. These documents automatically identified may not have been verified by the study sponsor.