NCT03284905CompletedNot Applicable
Probiotic Intervention for Acute Stress
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Probi AB
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Reduction of the cortisol level during acute stress
Study Overview
Brief Summary
Efficacy of probiotics on acute stress
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •19-35 years
- •SMBQ-score ≥3.75
- •Understand Swedish in spoken and written terms
- •Willing and able to give written informed consent for participating in the study
- •Intake of probiotics within two weeks prior to the start of the study
Exclusion Criteria
- •Antibiotic treatment in the last three months
- •Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness
- •Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment
Arms & Interventions
Probiotics
Active Comparator
Intervention: Probiotic supplement (Dietary Supplement)
Placebo
Placebo Comparator
Intervention: Placebo supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Reduction of the cortisol level during acute stress
Time Frame: 2.5 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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