None listed
Conditions
Brief summary
Background: University students experience higher levels of stress leading up to examinations. This study hypothesises that supplementation with probiotics will reduce the stress students experience before examinations. Participating students will be randomly assigned to take either probiotic or placebo capsules for the university semester. Student's stress levels, anxiety and psychological wellbeing will be measured before and after the intervention.
Interventions
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 probi
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.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
17 Years to 50 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed