Evaluation of a Probiotic On Anxiety and Stress in Health... | NCT00807157

Studies
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress

NCT00807157

Sponsor

Institut Rosell Lallemand

Status

Completed

Last Update Posted

Apr 24, 2009Estimated

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Anxiety
Stress

Interventions

PROBIOSTICK® during 30 days
Placebo during 30 days

Countries

France

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

Apr 2009

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

Dec 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 10, 2008

First Posted Date

Dec 11, 2008Estimated

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

Apr 23, 2009

Last Update Posted Date

Apr 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator	Every morning subjects will consume a stick of placebo during 30 days	Dietary Supplement: Placebo during 30 days
1	Experimental	Every morning subjects will consume a stick of PROBIOSTICK® during 30 days	Dietary Supplement: PROBIOSTICK® during 30 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PROBIOSTICK® during 30 days	Dietary Supplement	Every morning subjects will consume a stick of PROBIOSTICK® during 30 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCL 90 questionnaire		day 0 and day 30

Secondary Outcomes

Measure	Description	Time Frame
Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement		day-14 ; day 0 and day 30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian healthy men or women
Age 30-60 years
Hospital anxiety and depression score equal or below 12 and above 4
Standard safety biology

Exclusion Criteria:

HAD A results above 12 and below 4
HAD D results above 12
Neurologic or psychiatric pathology
Consumption of psychotropic
High level of caffeine consumption
Any important chronic pathology
Drugs wich impairs concentration, anxiety and stress

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided