Probiotic Intervention for Stress and Cognition

A Randomized, Double-blinded, Placebo-controlled, Parallel Clinical Trial of a Probiotic on Stress and Cognitive Function in Healthy Adults

The effect of probiotics on stress and cognitive function in healthy adults with moderate stress

Study Overview

• Status: Completed
• Conditions: Stress; Cognition
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Willing to participate in the study and comply with its procedures.
• Be able to give written informed consent.
• Be between 21 and 50 years.
• Have moderate stress, as measured on Cohen's Perceived Stress Scale (PSS).
• Are not suffering from depression or anxiety, confirmed by a Hospital Anxiety and Depression Scale (HADS) score.
• Are not regularly consuming probiotics for at least 4 weeks prior to the Screening Visit.
• Is in general good health, as determined by the investigator.

Exclusion Criteria:

• Current diagnosis of currently active irritable bowel syndrome (IBS), according to Rome IV criteria.
• Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment.
• Known gluten intolerance, lactose intolerance, milk protein allergy.
• Intake of antibiotics within four weeks prior to the Screening Visit.
• Hypersensitivity to any of the ingredients in the Investigational Product (IP).
• Previous (within 5 years) or ongoing psychiatric illness.
• Consumption of systemic psychotropics, rheumatoid drugs, steroid drugs or creams containing cortisone.
• Regular consumption of asthma medications.
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk if participating in the study, or influence the results or the participant´s ability to participate in the study.
• Investigator considers the participant unlikely to comply with study procedures, restrictions, and requirements.
• Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function.
• Participation in other clinical trials involving Investigational Product consumption in the last month.
• Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial.
• Participants who are pregnant, breastfeeding, or wish to become pregnant during the study.
• Participants currently of childbearing potential, but not using an effective method of contraception.
• Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
• Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
• Taking any supplements or vitamins notably known to affect cognitive function. Vitamin D and calcium supplements permitted if on a stable dose for the previous 3 months.
• History of heavy caffeinated beverage consumption (>400 mg caffeine/day) within past 2 weeks prior to the Screening Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; One capsule per day for 12 weeks	Dietary supplement: Probiotics; Capsule
Placebo Comparator: Placebo; One capsule per day for 12 weeks	Dietary supplement: Placebo; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether intake of probiotics reduce perceived stress	Perceived stress will be evaluated with Cohen's Perceived Stress Scale (PSS) (min 0, max 40)	12 weeks

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics; Gut-brain axis
• Other Study ID Numbers: AFCRO-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No