Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick). |
|
| Placebo | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProbioStick | Dietary Supplement | One sachet daily, without or without meals (3 x 10^9 CFU per sachet) (Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in right frontal electroencephalography (EEG)/brain activity | Is a measure of stress/arousal | Visit 1 and Visit 2 (6 weeks apart) |
| Changes in salivary cortisol concentrations | Collected via Salivette®, before and after each session in the lab. | Pre and Post Visit 1 and Visit 2 (6 weeks apart) |
| Change in the magnitude of startle response | Measured as facial electromyography (EMG) change | Visit 1 and Visit 2 (6 weeks apart) |
| Changes in sympathetic nervous system activation | Calculated as a measure of Heart Rate Variability (HRV) from electrocardiography (ECG) data | Visit 1 and Visit 2 (6 weeks apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Anxiety Scores as determined by the Beck Anxiety Inventory (BAI) | Visit 1 and Visit 2 (6 weeks apart) | |
| Changes in Stress Scores as determined by Cohen's Perceived Stress Scale (PSS) | Visit 1 and Visit 2 (6 weeks apart) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurel Trainor, Ph.D. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster LIVELab | Hamilton | Ontario | L8S 4L8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18537636 | Background | Lutgendorff F, Akkermans LM, Soderholm JD. The role of microbiota and probiotics in stress-induced gastro-intestinal damage. Curr Mol Med. 2008 Jun;8(4):282-98. doi: 10.2174/156652408784533779. | |
| 24372793 | Background | Ait-Belgnaoui A, Colom A, Braniste V, Ramalho L, Marrot A, Cartier C, Houdeau E, Theodorou V, Tompkins T. Probiotic gut effect prevents the chronic psychological stress-induced brain activity abnormality in mice. Neurogastroenterol Motil. 2014 Apr;26(4):510-20. doi: 10.1111/nmo.12295. Epub 2013 Dec 30. |
| Label | URL |
|---|---|
| McMaster LIVELab | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | One sachet daily, without or without meals (0 CFU per sachet) |
|
| Changes in General Affect Scores as determined by the Positive and Negative Affect Scale (PANAS) | Visit 1 and Visit 2 (6 weeks apart) |
| Changes in Stress Scores as reported on a 1-10 Likert Scale | Visit 1 and Visit 2 (6 weeks apart) |
| 22541937 | Background | Ait-Belgnaoui A, Durand H, Cartier C, Chaumaz G, Eutamene H, Ferrier L, Houdeau E, Fioramonti J, Bueno L, Theodorou V. Prevention of gut leakiness by a probiotic treatment leads to attenuated HPA response to an acute psychological stress in rats. Psychoneuroendocrinology. 2012 Nov;37(11):1885-95. doi: 10.1016/j.psyneuen.2012.03.024. Epub 2012 Apr 26. |
| 24016865 | Background | Palomar MM, Maldonado Galdeano C, Perdigon G. Influence of a probiotic lactobacillus strain on the intestinal ecosystem in a stress model mouse. Brain Behav Immun. 2014 Jan;35:77-85. doi: 10.1016/j.bbi.2013.08.015. Epub 2013 Sep 7. |
| 12908907 | Background | Kullisaar T, Songisepp E, Mikelsaar M, Zilmer K, Vihalemm T, Zilmer M. Antioxidative probiotic fermented goats' milk decreases oxidative stress-mediated atherogenicity in human subjects. Br J Nutr. 2003 Aug;90(2):449-56. doi: 10.1079/bjn2003896. |
| 21983070 | Background | Messaoudi M, Violle N, Bisson JF, Desor D, Javelot H, Rougeot C. Beneficial psychological effects of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in healthy human volunteers. Gut Microbes. 2011 Jul-Aug;2(4):256-61. doi: 10.4161/gmic.2.4.16108. Epub 2011 Jul 1. No abstract available. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| Background | Lang PJ, Bradley MM, Cuthbert BN. International affective picture system (IAPS): Affective ratings of pictures and instruction manual.. Technical Report A-8. University of Florida, Gainesville, FL.; 1995. |
| Background | Gasser F. Safety of lactic acid bacteria and their occurrence in human clinical infections. Bull Inst Past. 1994;92:45-67. |
| 9849787 | Background | Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM, Fonden R, Saxelin M, Collins K, Mogensen G, Birkeland SE, Mattila-Sandholm T. Demonstration of safety of probiotics -- a review. Int J Food Microbiol. 1998 Oct 20;44(1-2):93-106. doi: 10.1016/s0168-1605(98)00128-7. |
| Background | European Food Safety Authority. Guidance on the assessment of bacterial susceptibility to antimicrobials of human and veterinary importance. EFSA Journal. 2012;10(6). |
| 21083822 | Background | Garneau P, Labrecque O, Maynard C, Messier S, Masson L, Archambault M, Harel J. Use of a bacterial antimicrobial resistance gene microarray for the identification of resistant Staphylococcus aureus. Zoonoses Public Health. 2010 Nov;57 Suppl 1:94-9. doi: 10.1111/j.1863-2378.2010.01358.x. |
| McMaster SONA Recruitment | View source |
| Lallemand Health Solutions | View source |