- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417454
Study on the Effects of a Probiotic on Autonomic and Psychological Stress
A Double Blind Placebo Controlled Study on the Effects of a Probiotic on Autonomic and Psychological Stress Responses in Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- McMaster LIVELab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
Participants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick).
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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: Placebo
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
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One sachet daily, without or without meals (0 CFU per sachet)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in right frontal electroencephalography (EEG)/brain activity
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Is a measure of stress/arousal
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Visit 1 and Visit 2 (6 weeks apart)
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Changes in salivary cortisol concentrations
Time Frame: Pre and Post Visit 1 and Visit 2 (6 weeks apart)
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Collected via Salivette®, before and after each session in the lab.
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Pre and Post Visit 1 and Visit 2 (6 weeks apart)
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Change in the magnitude of startle response
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Measured as facial electromyography (EMG) change
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Visit 1 and Visit 2 (6 weeks apart)
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Changes in sympathetic nervous system activation
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Calculated as a measure of Heart Rate Variability (HRV) from electrocardiography (ECG) data
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Visit 1 and Visit 2 (6 weeks apart)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Anxiety Scores as determined by the Beck Anxiety Inventory (BAI)
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Visit 1 and Visit 2 (6 weeks apart)
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Changes in Stress Scores as determined by Cohen's Perceived Stress Scale (PSS)
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Visit 1 and Visit 2 (6 weeks apart)
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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)
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Visit 1 and Visit 2 (6 weeks apart)
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Changes in Stress Scores as reported on a 1-10 Likert Scale
Time Frame: Visit 1 and Visit 2 (6 weeks apart)
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Visit 1 and Visit 2 (6 weeks apart)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurel Trainor, Ph.D., McMaster University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gasser F. Safety of lactic acid bacteria and their occurrence in human clinical infections. Bull Inst Past. 1994;92:45-67.
- European Food Safety Authority. Guidance on the assessment of bacterial susceptibility to antimicrobials of human and veterinary importance. EFSA Journal. 2012;10(6).
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20000229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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