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CompletedNCT04931082Updated Nov 18, 2023

Probiotic Intervention for Stress and Cognition

An interventional study of Probiotics and Placebo in Stress and Cognition, sponsored by Probi AB. Completed at 1 site in Ireland. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Stress
  • Cognition

Keywords

  • Gut-brain axis
  • Probiotics
03

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (actual)

Study arms

  • Active comparator
    Probiotics

    One capsule per day for 12 weeks

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    One capsule per day for 12 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics

    Capsule

  • Dietary supplementPlacebo

    Capsule

05

What researchers measure

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)

    Time frame: 12 weeks

06

Study locations

1 site
  • Atlantia Food Clinical Trials
    Cork, Ireland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04931082
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
Jul 7, 2021
Primary completion
Mar 25, 2022
Completion
Mar 21, 2023
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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