Psychological StressNCT02378610
Relationship Between the Gut Microbiota and Stress
An observational study of Psychological Stress, run by Lund University at 1 site in Sweden.
Trial summary
The relationship between the gut microbiota and stress is poorly studied in humans. In this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons. 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
- Psychological Stress
- What is being tested?
- Observation
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- Feb 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, 19-35 years old.
Who may be able to join
- Healthy man between 19-35 years old
Who cannot join
- Antibiotic intake
- Gastrointestinal diseases
- Diabetes
- Phsycological diseases
- Tyroid related diseases
- Cardiovascular diseases
- Celiaki
- Cortisone drugs
Trial locations and contacts
1 site in 1 country.
About this study
The relationship between the gut microbiota and stress is poorly studied in humans. In this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons.
Read the detailed description
The gut microbial flora will be analyzed with molecular genetic methods. Stress will be measured with cortisol levels in saliva and with questionnaire.
- Conditions
- Psychological Stress
- Being tested
- Observation
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of the gut bacterial flora in high- and low-stressed individuals
| Study group | Role | What they receive |
|---|---|---|
| Observation in High-stressed | Saliva and fecal samples will be collected from High-stressed persons Receives: Other: Observation | |
| Observation in Low-stressed | Saliva and fecal samples will be collected from Low-stressed persons Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of the gut microbiota
Measured: May 2015-January 2016
Secondary outcomes (1)
Markers of stress
Measured: April 2015-January 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 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 Psychological StressStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 59 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
- NCT02378610
- Sponsor's protocol ID
- SP14_CarolineLinninge
- Status last verified
- Sep 2017
- First submitted
- 27 Feb 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Gut Microbiota and Stress
- ClinicalTrials.gov ID
- NCT02378610
- Acronym / sponsor ID
- SP14_CarolineLinninge
- Conditions
- Psychological Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Mar 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 relationship between the gut microbiota and stress is poorly studied in humans. In this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons.
Detailed description
The gut microbial flora will be analyzed with molecular genetic methods. Stress will be measured with cortisol levels in saliva and with questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation in High-stressed | – | Other: ObservationSaliva and fecal samples will be collected from High-stressed persons |
| Observation in Low-stressed | – | Other: ObservationSaliva and fecal samples will be collected from Low-stressed persons |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Men, 19-35 years old.
Key inclusion criteria (1 listed)
- Healthy man between 19-35 years old
Key exclusion criteria (8 listed)
- Antibiotic intake
- Gastrointestinal diseases
- Diabetes
- Phsycological diseases
- Tyroid related diseases
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 |
|---|---|---|
| ObservationObservation of the gut bacterial flora in high- and low-stressed individuals | Other | Observation in High-stressed, Observation in Low-stressed |
Primary outcome
Markers of the gut microbiota
Time frame: May 2015-January 2016
1 secondary outcome
Markers of stress
Time frame: April 2015-January 2016
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 11 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 Psychological 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 1 inclusion and 8 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 11 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?
Markers of the gut microbiota (time frame: May 2015-January 2016). 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 11 Sep 2017.