StressNCT04931082
Probiotic Intervention for Stress and Cognition
A study testing Probiotics in people with Stress and Cognition, run by Probi AB at 1 site in Ireland.
Trial summary
The effect of probiotics on stress and cognitive function in healthy adults with moderate stress Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteIreland
- Study dates
- 7 Jul 2021to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Parallel Clinical Trial of a Probiotic on Stress and Cognitive Function in Healthy Adults
The effect of probiotics on stress and cognitive function in healthy adults with moderate stress
- Being tested
- Probiotics, Placebo
- Keywords
- Gut-brain axis, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Capsule
PlaceboDietary supplement
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | One capsule per day for 12 weeks Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | One capsule per day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether intake of probiotics reduce perceived stress
Perceived stress will be evaluated with Cohen's Perceived Stress Scale (PSS) (min 0, max 40)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 Jul 2021
- Primary completion25 Mar 2022
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931082
- Sponsor's protocol ID
- AFCRO-136
- Status last verified
- Nov 2023
- First submitted
- 7 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Parallel Clinical Trial of a Probiotic on Stress and Cognitive Function in Healthy Adults
- ClinicalTrials.gov ID
- NCT04931082
- Acronym / sponsor ID
- AFCRO-136
- Keywords
- Gut-brain axis, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of probiotics on stress and cognitive function in healthy adults with moderate stress
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsOne capsule per day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule per day for 12 weeks |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsCapsule | Dietary supplement | Probiotics |
| PlaceboCapsule | Dietary supplement | Placebo |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Stress and Cognition, run by Probi AB at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether intake of probiotics reduce perceived stress (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.