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OpenTrials
Completed

NCT Number: NCT04931082

Probiotic Intervention for Stress and Cognition

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

Completed

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

Capsule

Placebo

Dietary Supplement

Capsule

Primary outcomes

  1. Determine whether intake of probiotics reduce perceived stress

    Time frame: 12 weeks

    Perceived stress will be evaluated with Cohen's Perceived Stress Scale (PSS) (min 0, max 40)

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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