NCT02378610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

February 27, 2015

Last Update Submit

September 6, 2017

Conditions

Psychological Stress

Outcome Measures

Primary Outcomes (1)

  • Markers of the gut microbiota

    May 2015-January 2016

Secondary Outcomes (1)

  • Markers of stress

    April 2015-January 2016

Study Arms (2)

Observation in High-stressed

Saliva and fecal samples will be collected from High-stressed persons

Other: Observation

Observation in Low-stressed

Saliva and fecal samples will be collected from Low-stressed persons

Other: Observation

Interventions

ObservationOTHER

Observation of the gut bacterial flora in high- and low-stressed individuals

Observation in High-stressedObservation in Low-stressed

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy Men, 19-35 years old.

You may qualify if:

  • Healthy man between 19-35 years old

You may not qualify if:

  • Antibiotic intake
  • Gastrointestinal diseases
  • Diabetes
  • Phsycological diseases
  • Tyroid related diseases
  • Cardiovascular diseases
  • Celiaki
  • Cortisone drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, 221 00, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Stress, Psychological

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Caroline Linninge, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

SE(1)