Relationship Between the Gut Microbiota and Stress | NCT02378610

Studies
Relationship Between the Gut Microbiota and Stress

NCT02378610

Sponsor

Lund University

Status

Completed

Last Update Posted

Sep 11, 2017Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Psychological Stress

Interventions

Observation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Feb 27, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2017

Last Update Posted Date

Sep 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observation of the gut bacterial flora in high- and low-stressed individuals	Observation in High-stressed Observation in Low-stressed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Markers of the gut microbiota		May 2015-January 2016

Secondary Outcomes

Measure	Description	Time Frame
Markers of stress		April 2015-January 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy man between 19-35 years old

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Healthy Men, 19-35 years old.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline Linninge, PhD	Lund University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lund University		Lund		221 00	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided