Effect of Probiotics on Stress in Young Adults

Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study

The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).

Study Overview

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

Detailed Description

The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.

At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.

At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to give informed e-consent
• Be between 18 and 45 years old, inclusive
• In general good health, as determined by the investigator
• Have a BMI of ≥18.5 and <30.0 kg/m2
• Willing to consume the study product daily for the duration of the study and comply with the study procedures
• Have moderate stress, as measured on the Cohen's Perceived Stress Scale, with a score between 14 and 26 (inclusive)
• Be able to communicate well with the Investigator, to understand and comply with the study requirements and be judged suitable for the study in the opinion of the investigator

Exclusion Criteria:

• Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9)
• Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months
• Have a known major stressful life event occurring (current or upcoming) during the study
• Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD)
• Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function
• Use of oral or systemic (topical allowed) immunosuppressant drugs, antibiotics, steroids, etc. within the one month before screening
• Consumption of probiotic supplements that contain live bacteria in the 4 weeks before the screening
• Regular use of anti-inflammatory drugs such as aspirin or ibuprofen (>200mg/24 hours)
• Food allergy or hypersensitivity to any component of the product
• Heavy alcohol use or recent history (within one year) of illicit drug use
• Participants who work night shifts
• Participation in other clinical trials or studies in the last month
• Desire and/or plans on changing current diet and/or exercise regime during the participation of this study
• Participants who are pregnant or wish to become pregnant during the study
• Participants who are lactating and/or currently breastfeeding
• Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator
• Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics combined strains; Probiotics combined strains administered as oral capsules once daily	Dietary supplement: Probiotics; Oral capsules
Experimental: Probiotics single strain; Probiotics single strain administered as oral capsules once daily	Dietary supplement: Probiotics; Oral capsules
Placebo Comparator: Placebo; Placebo capsule administered orally once daily	Dietary supplement: Placebo; Oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST	Before, during, and after TSST at visit 2 (week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI score	Change in State-Trait Anxiety Index (STAI) in response to TSST. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety.	Before and after TSST at visit 2 (week 8)
PSS score	Change in Cohen's Perceived Stress Scale (PSS) from baseline to week 8. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	baseline and week 8
STAI score	Change in State-Trait Anxiety Index (STAI) from baseline to week 8. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety.	baseline and week 8
Anxiety	Change in Anxiety Visual Analog Scale (VAS) in response to TSST	Before, during, and after TSST at visit 2 (week 8)
Emotional insecurity	Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST	Before, during, and after TSST at visit 2 (week 8)
Exhaustion	Change in Exhaustion Visual Analog Scale (VAS) in response to TSST	Before, during, and after TSST at visit 2 (week 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol	Salivary cortisol levels in response to TSST	Before, during, and after TSST at visit 2 (week 8)
Inflammatory biomarker IL-6	Blood inflammatory biomarkers from baseline to week 8	baseline and week 8
Inflammatory biomarker IL-10	Blood inflammatory biomarkers from baseline to week 8	baseline and week 8

Collaborators and Investigators

• Sponsor: Chr Hansen
• Investigators: Principal Investigator: Timothy Dinan, Professor, Atlantia Clinical Trials Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Stress
• Other Study ID Numbers: HND-MH-052

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