StressNCT05840978
Effect of Probiotics on Stress in Young Adults
A study testing Probiotics in people with Stress, run by Chr Hansen at 1 site in Ireland.
Trial summary
The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- 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
- 240 participants
- Where
- 1 siteIreland
- Study dates
- 5 Apr 2023to 11 Dec 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to give informed e-consent
- Be between 18 and 45 years old, inclusive
- In general good health, as determined by the investigator
- Have a BMI of ≥18.5 and <30.0 kg/m2
- Willing to consume the study product daily for the duration of the study and comply with the study procedures
- Have moderate stress, as measured on the Cohen's Perceived Stress Scale, with a score between 14 and 26 (inclusive)
- Be able to communicate well with the Investigator, to understand and comply with the study requirements and be judged suitable for the study in the opinion of the investigator
Who cannot join
- Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9)
- Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months
- Have a known major stressful life event occurring (current or upcoming) during the study
- Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD)
- Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function
- Use of oral or systemic (topical allowed) immunosuppressant drugs, antibiotics, steroids, etc. within the one month before screening
Show all 17Show fewer
- Consumption of probiotic supplements that contain live bacteria in the 4 weeks before the screening
- Regular use of anti-inflammatory drugs such as aspirin or ibuprofen (>200mg/24 hours)
- Food allergy or hypersensitivity to any component of the product
- Heavy alcohol use or recent history (within one year) of illicit drug use
- Participants who work night shifts
- Participation in other clinical trials or studies in the last month
- Desire and/or plans on changing current diet and/or exercise regime during the participation of this study
- Participants who are pregnant or wish to become pregnant during the study
- Participants who are lactating and/or currently breastfeeding
- Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator
- Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study
The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).
Read the detailed description
The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.
At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.
At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.
- Conditions
- Stress
- Being tested
- Probiotics, Placebo
- Keywords
- Stress, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Oral capsules
PlaceboDietary supplement
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Probiotics combined strains | Experimental | Probiotics combined strains administered as oral capsules once daily Receives: Dietary Supplement: Probiotics |
| Probiotics single strain | Experimental | Probiotics single strain administered as oral capsules once daily Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo capsule administered orally once daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST
Measured: Before, during, and after TSST at visit 2 (week 8)
Secondary outcomes (6)
STAI score
Change in State-Trait Anxiety Index (STAI) in response to TSST. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety.
Measured: Before and after TSST at visit 2 (week 8)
PSS score
Change in Cohen's Perceived Stress Scale (PSS) from baseline to week 8. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: baseline and week 8
STAI score
Change in State-Trait Anxiety Index (STAI) from baseline to week 8. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety.
Measured: baseline and week 8
Anxiety
Change in Anxiety Visual Analog Scale (VAS) in response to TSST
Measured: Before, during, and after TSST at visit 2 (week 8)
Emotional insecurity
Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST
Measured: Before, during, and after TSST at visit 2 (week 8)
Exhaustion
Change in Exhaustion Visual Analog Scale (VAS) in response to TSST
Measured: Before, during, and after TSST at visit 2 (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Apr 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Professor, Principal investigator, Atlantia Clinical Trials Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840978
- Sponsor's protocol ID
- HND-MH-052
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2023
- Last updated
- 15 Dec 2023
- Results posted
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05840978
- Acronym / sponsor ID
- HND-MH-052
- Conditions
- Stress
- Keywords
- Stress, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 3 May 2023 (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 study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).
Detailed description
The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.
At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.
At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics combined strains | Experimental | Dietary Supplement: ProbioticsProbiotics combined strains administered as oral capsules once daily |
| Probiotics single strain | Experimental | Dietary Supplement: ProbioticsProbiotics single strain administered as oral capsules once daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule administered orally once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to give informed e-consent
- Be between 18 and 45 years old, inclusive
- In general good health, as determined by the investigator
- Have a BMI of ≥18.5 and <30.0 kg/m2
- Willing to consume the study product daily for the duration of the study and comply with the study procedures
Key exclusion criteria (17 listed)
- Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9)
- Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months
- Have a known major stressful life event occurring (current or upcoming) during the study
- Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD)
- Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function
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 |
|---|---|---|
| ProbioticsOral capsules | Dietary supplement | Probiotics combined strains, Probiotics single strain |
| PlaceboOral capsules | Dietary supplement | Placebo |
Primary outcome
Perceived stress
Time frame: Before, during, and after TSST at visit 2 (week 8)
Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST
6 secondary outcomes
STAI score
Time frame: Before and after TSST at visit 2 (week 8)
PSS score
Time frame: baseline and week 8
STAI score
Time frame: baseline and week 8
Anxiety
Time frame: Before, during, and after TSST at visit 2 (week 8)
Emotional insecurity
Time frame: Before, during, and after TSST at visit 2 (week 8)
Exhaustion
Time frame: Before, during, and after TSST at visit 2 (week 8)
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 15 Dec 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.
Timothy Dinan, Professor principal investigator
Atlantia Clinical Trials Ltd
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, run by Chr Hansen 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 17 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 15 Dec 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?
Perceived stress (time frame: Before, during, and after TSST at visit 2 (week 8)). 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 15 Dec 2023.