Stress, PsychologicalPhase 3NCT02417454
Study on the Effects of a Probiotic on Autonomic and Psychological Stress
A Phase 3 study testing ProbioStick in people with Stress, Psychological, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- ProbioStick
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Placebo Controlled Study on the Effects of a Probiotic on Autonomic and Psychological Stress Responses in Volunteers
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- ProbioStick, Placebo
- Keywords
- probiotic, stress, emotion psychophysiology, brain-body-gut interactions
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioStickDietary supplement
One sachet daily, without or without meals (3 x 10^9 CFU per sachet)
(Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175)
PlaceboOther
One sachet daily, without or without meals (0 CFU per sachet)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick). Receives: Dietary 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in right frontal electroencephalography (EEG)/brain activity
Is a measure of stress/arousal
Measured: Visit 1 and Visit 2 (6 weeks apart)
Changes in salivary cortisol concentrations
Collected via Salivette®, before and after each session in the lab.
Measured: Pre and Post Visit 1 and Visit 2 (6 weeks apart)
Change in the magnitude of startle response
Measured as facial electromyography (EMG) change
Measured: 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
Measured: Visit 1 and Visit 2 (6 weeks apart)
Secondary outcomes (4)
Changes in Anxiety Scores as determined by the Beck Anxiety Inventory (BAI)
Measured: Visit 1 and Visit 2 (6 weeks apart)
Changes in Stress Scores as determined by Cohen's Perceived Stress Scale (PSS)
Measured: Visit 1 and Visit 2 (6 weeks apart)
Changes in General Affect Scores as determined by the Positive and Negative Affect Scale (PANAS)
Measured: Visit 1 and Visit 2 (6 weeks apart)
Changes in Stress Scores as reported on a 1-10 Likert Scale
Measured: Visit 1 and Visit 2 (6 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Laurel Trainor, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417454
- Sponsor's protocol ID
- 20000229
- Status last verified
- Oct 2017
- First submitted
- 7 Apr 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18537636Ait-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.
PubMed 24372793Ait-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.
PubMed 22541937Palomar 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.
PubMed 24016865Kullisaar 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.
PubMed 12908907Messaoudi 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.
PubMed 21983070Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Lang 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.
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.
PubMed 9849787European 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.
PubMed 21083822
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Study on the Effects of a Probiotic on Autonomic and Psychological Stress Responses in Volunteers
- ClinicalTrials.gov ID
- NCT02417454
- Acronym / sponsor ID
- 20000229
- Conditions
- Stress, Psychological
- Keywords
- probiotic, stress, emotion psychophysiology, brain-body-gut interactions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioStickParticipants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick). |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioStickOne sachet daily, without or without meals (3 x 10^9 CFU per sachet) (Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175) | Dietary supplement | Probiotic |
| PlaceboOne sachet daily, without or without meals (0 CFU per sachet) | Other | Placebo |
Primary outcome
Changes in right frontal electroencephalography (EEG)/brain activity
Time frame: Visit 1 and Visit 2 (6 weeks apart)
Is a measure of stress/arousal
Changes in salivary cortisol concentrations
Time frame: Pre and Post Visit 1 and Visit 2 (6 weeks apart)
Collected via Salivette®, before and after each session in the lab.
Change in the magnitude of startle response
Time frame: Visit 1 and Visit 2 (6 weeks apart)
Measured as facial electromyography (EMG) change
Changes in sympathetic nervous system activation
Time frame: Visit 1 and Visit 2 (6 weeks apart)
Calculated as a measure of Heart Rate Variability (HRV) from electrocardiography (ECG) data
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 18537636Lutgendorff 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.
- Background: PubMed 24372793Ait-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.
- Background: PubMed 22541937Ait-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.
- Background: PubMed 24016865Palomar 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.
- Background: PubMed 12908907Kullisaar 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.
- Background: PubMed 21983070Messaoudi 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundLang 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.
- BackgroundGasser F. Safety of lactic acid bacteria and their occurrence in human clinical infections. Bull Inst Past. 1994;92:45-67.
- Background: PubMed 9849787Salminen 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.
- BackgroundEuropean Food Safety Authority. Guidance on the assessment of bacterial susceptibility to antimicrobials of human and veterinary importance. EFSA Journal. 2012;10(6).
- Background: PubMed 21083822Garneau 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 LIVELabLink provided by the sponsor.
- McMaster SONA RecruitmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel Trainor, Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ProbioStick in people with Stress, Psychological, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in right frontal electroencephalography (EEG)/brain activity (time frame: Visit 1 and Visit 2 (6 weeks apart)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417454, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.