- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284905
Probiotic Intervention for Acute Stress
March 19, 2019 updated by: Probi AB
Efficacy of probiotics on acute stress
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, 223 00
- Department of Food Technology, Engineering and Nutrition, Lund University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- BMI> 30
- Pregnant
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Capsule containing maize starch
|
Active Comparator: Probiotics
|
Capsule containing freeze dried probiotic bacteria together with maize starch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of the cortisol level during acute stress
Time Frame: 2.5 hours
|
2.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2017
Primary Completion (Actual)
April 4, 2018
Study Completion (Actual)
April 4, 2018
Study Registration Dates
First Submitted
September 13, 2017
First Submitted That Met QC Criteria
September 13, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
March 20, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- SP17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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