Probiotic Intervention for Stress and Cognition

NCT04931082 | Completed

• 1 other identifier: AFCRO-136
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress; Cognition

Keywords

Gut-brain axis; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

One capsule per day for 12 weeks

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

One capsule per day for 12 weeks

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Capsule

Probiotics

Placebo DIETARY_SUPPLEMENT

Capsule

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: July 7, 2021
• Primary Completion: March 25, 2022
• Study Completion: March 21, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)