Probiotic Intervention for Stress and Cognition

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931082
• Other study ID #: AFCRO-136
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: March 21, 2023

Study information

• Verified date: November 2023
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 21, 2023
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Stress

Intervention

Dietary Supplement:
• Probiotics
Capsule
• Placebo
Capsule

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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