Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2023-04-05
2023-12-11
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Probiotics combined strains
Probiotics combined strains administered as oral capsules once daily
Probiotics
Oral capsules
Probiotics single strain
Probiotics single strain administered as oral capsules once daily
Probiotics
Oral capsules
Placebo
Placebo capsule administered orally once daily
Placebo
Oral capsules
Interventions
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Probiotics
Oral capsules
Placebo
Oral capsules
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Chr Hansen
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Dinan, Professor
Role: PRINCIPAL_INVESTIGATOR
Atlantia Clinical Trials Ltd
Locations
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Atlantia clinical trials
Cork, , Ireland
Countries
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Other Identifiers
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HND-MH-052
Identifier Type: -
Identifier Source: org_study_id