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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02417454
Enrollment
128
Registered
2015-04-15
Start date
2015-09-30
Completion date
2017-08-31
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Psychological

Keywords

probiotic, stress, emotion psychophysiology, brain-body-gut interactions

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTProbioStick

One sachet daily, without or without meals (3 x 10\^9 CFU per sachet) (Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175)

OTHERPlacebo

One sachet daily, without or without meals (0 CFU per sachet)

Sponsors

Lallemand Health Solutions
CollaboratorINDUSTRY
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in sympathetic nervous system activationVisit 1 and Visit 2 (6 weeks apart)Calculated as a measure of Heart Rate Variability (HRV) from electrocardiography (ECG) data
Changes in right frontal electroencephalography (EEG)/brain activityVisit 1 and Visit 2 (6 weeks apart)Is a measure of stress/arousal
Changes in salivary cortisol concentrationsPre 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 responseVisit 1 and Visit 2 (6 weeks apart)Measured as facial electromyography (EMG) change

Secondary

MeasureTime 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)
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 ScaleVisit 1 and Visit 2 (6 weeks apart)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026