Overview

This trial is active, not recruiting.

Condition stress, psychological
Treatments probiostick, placebo
Phase phase 3
Sponsor McMaster University
Collaborator Lallemand Health Solutions
Start date September 2015
End date April 2016
Trial size 128 participants
Trial identifier NCT02417454, 20000229

Summary

The purpose of this study is to investigate the effects of a probiotic blend on qualitative (subjective interviews and self-reporting) and quantitative (changes in brain activity, heart rate, cortisol, and reactivity) measures of stress in healthy undergraduate students.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick).
probiostick
One sachet daily, without or without meals (3 x 10^9 CFU per sachet) (Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175)
(Placebo Comparator)
Participants will undergo the same study procedures as for the probiotic; however, the product given will be a placebo, identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients in the probiotic supplement
placebo
One sachet daily, without or without meals (0 CFU per sachet)

Primary Outcomes

Measure
Changes in right frontal electroencephalography (EEG)/brain activity
time frame: Visit 1 and Visit 2 (6 weeks apart)
Changes in salivary cortisol concentrations
time frame: Pre and Post Visit 1 and Visit 2 (6 weeks apart)
Change in the magnitude of startle response
time frame: Visit 1 and Visit 2 (6 weeks apart)
Changes in sympathetic nervous system activation
time frame: Visit 1 and Visit 2 (6 weeks apart)

Secondary Outcomes

Measure
Changes in Anxiety Scores as determined by the Beck Anxiety Inventory (BAI)
time frame: Visit 1 and Visit 2 (6 weeks apart)
Changes in Stress Scores as determined by Cohen's Perceived Stress Scale (PSS)
time frame: Visit 1 and Visit 2 (6 weeks apart)
Changes in General Affect Scores as determined by the Positive and Negative Affect Scale (PANAS)
time frame: Visit 1 and Visit 2 (6 weeks apart)
Changes in Stress Scores as reported on a 1-10 Likert Scale
time frame: Visit 1 and Visit 2 (6 weeks apart)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Answering "Yes" to questions 3, 8 and 9 of the Cohen's Perceived Stress Scale. - Willingness to complete questionnaires, records, and diaries associated with the study and to complete all site visits. - Willingness to discontinue consumption of fermented foods or probiotics (e.g. yogurts, with live, active cultures, or supplements). - Ability to provide informed consent. Exclusion Criteria: - Must not be currently taking another probiotic regiment or another investigational product within 3 months of the screening visit. - Must not currently be taking medications for depression or anxiety, including benzodiazepines, SSRIs, or antipsychotics or receiving counselling for depression or anxiety. - Must not be immune-compromised or immuno-suppressed (e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants). - Must not have experienced bloody diarrhea in the past month prior to beginning the study. - Must not have undergone any surgery within the three months prior to beginning the study, particularly surgeries involving the colon. - Must not have any soy or milk allergy. - Must not be pregnant or breast-feeding or planning on becoming pregnant. - Must not have used of any antibiotic drug (e.g., neomycin, rifaximin) within 1 month of screening.

Additional Information

Official title A Double Blind Placebo Controlled Study on the Effects of a Probiotic on Autonomic and Psychological Stress Responses in Volunteers
Principal investigator Laurel Trainor, Ph.D.
Description There is a burgeoning literature involving nonhuman animal and human studies linking the microbiota environment in the gut to brain-behaviour relations. For example, animal studies demonstrate that germ-free rodents show heightened HPA-axis responses to stress compared to gnotobiotic animals. There are also a number of nonhuman and human studies that show positive effects of reducing stress after being treated with different probiotics. For example, in one recent double blind study in humans using standardized questionnaires indicated a greater reduction of stress and anxiety symptoms after one month of supplementation with a probiotic formulation compared to placebo. The groups were also differentiated by urinary cortisol levels after treatment. Other studies have found positive effects of probiotic treatment and stress reduction using other probiotics. Accordingly, there is accumulating empirical evidence from animal and human studies of the positive effects of probiotic treatment on stress reduction. In this study, the investigators will investigate the stress reduction effects of the Lallemand Health Solutions (LHS) Probio'Stick® on healthy undergraduate students. The study will be conducted at the McMaster LIVELab, which is capable of collecting both physiological and behavioural measures from groups of up to 100 participants at a time. Registration into this clinical trial will require students be screened via McMaster's SONA system (mcmaster.sona-systems.com). After the screening, participants that are eligible to participate will be given the option to register for an information meeting at which point one may opt to enrol in the study or not. Once in the study, participants will undergo an initial screening in the LIVELab where they will be exposed to auditory, visual, and performance based stressors to measure a baseline. After such point, they will be randomized to receive Probio'Stick® or placebo for a 6-week, once daily, probiotic treatment at home. Following the 6 week intervention, participants will return to the lab for a second testing using the same procedures to establish a change from baseline.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by McMaster University.