NCT02417454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

April 7, 2015

Last Update Submit

October 17, 2017

Conditions

Stress, Psychological

Keywords

probioticstressemotion psychophysiologybrain-body-gut interactions

Outcome Measures

Primary Outcomes (4)

  • 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)

Secondary Outcomes (4)

  • 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 Scale

    Visit 1 and Visit 2 (6 weeks apart)

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants will undergo the same study procedures as for the comparator; however, the product given will be the active probiotic supplement (ProbioStick).

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

Other: Placebo

Interventions

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)

Probiotic
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster LIVELab

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (12)

  • 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.

    PMID: 18537636BACKGROUND

  • 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.

    PMID: 24372793BACKGROUND

  • 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.

    PMID: 22541937BACKGROUND

  • 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.

    PMID: 24016865BACKGROUND

  • 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.

    PMID: 12908907BACKGROUND

  • 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.

    PMID: 21983070BACKGROUND

  • 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.

    PMID: 6668417BACKGROUND

  • 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.

    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.

    PMID: 9849787BACKGROUND

  • European Food Safety Authority (EFSA). Technical guidance - Update of the criteria used in the assessment of bacterial resistance to antibiotics of human or veterinary importance. EFSA J. 2008 Jul 14;6(7):732. doi: 10.2903/j.efsa.2008.732. eCollection 2008 Jul. No abstract available.

    PMID: 37213835BACKGROUND

  • 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.

    PMID: 21083822BACKGROUND

Related Links

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Laurel Trainor, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 15, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

CA(1)