StressSP15NCT02485405
Gut Permeability and Stress
An observational study of Stress, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to analyse gut permeability and stress. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Trier social stress test
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to Sep 2017
- Phase
- Observational
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy men aged 19-35 years old
Who may be able to join
- Man, 19-35 years old
- Healthy
Who cannot join
- Psychological disorders
- Use of antibiotics or other drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Permeability in Volunteers Participating in a Stress Test
The purpose of this study is to analyse gut permeability and stress.
Read the detailed description
Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.
Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.
- Conditions
- Stress
- Being tested
- Trier social stress test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier social stress testOther
Volunteers perform Trier social stress test
| Study group | Role | What they receive |
|---|---|---|
| stressed | stressed volunteers perform Trier social stress test Receives: Other: Trier social stress test | |
| non-stressed | non-stressed volunteers perform Trier social stress test Receives: Other: Trier social stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test
Measured: Volunteers will be followed by one hour after Trier social stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Linninge, Lund University
- Investigators
- Caroline Linninge, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485405
- Sponsor's protocol ID
- SP15_CarolineLinninge
- Acronym
- SP15
- Status last verified
- Sep 2017
- First submitted
- 23 Jun 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Permeability in Volunteers Participating in a Stress Test
- ClinicalTrials.gov ID
- NCT02485405
- Acronym / sponsor ID
- SP15 / SP15_CarolineLinninge
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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 purpose of this study is to analyse gut permeability and stress.
Detailed description
Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.
Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stressed | – | Other: Trier social stress teststressed volunteers perform Trier social stress test |
| non-stressed | – | Other: Trier social stress testnon-stressed volunteers perform Trier social stress test |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men aged 19-35 years old
Key inclusion criteria (2 listed)
- Man, 19-35 years old
- Healthy
Key exclusion criteria (2 listed)
- Psychological disorders
- Use of antibiotics or other drugs
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 |
|---|---|---|
| Trier social stress testVolunteers perform Trier social stress test | Other | non-stressed, stressed |
Primary outcome
gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test
Time frame: Volunteers will be followed by one hour after Trier social stress test
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 7 Sep 2017.
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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.
Caroline Linninge, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Lund University at 1 site in Sweden.
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 2 inclusion and 2 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 7 Sep 2017. 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 Sweden. 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. 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?
gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test (time frame: Volunteers will be followed by one hour after Trier social stress test). 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 7 Sep 2017.