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

NCT ID: NCT00807157

Last Updated: 2009-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Anxiety Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Every morning subjects will consume a stick of placebo during 30 days

Group Type PLACEBO_COMPARATOR

Placebo during 30 days

Intervention Type DIETARY_SUPPLEMENT

Every morning subjects will consume a stick of placebo during 30 days

1

Every morning subjects will consume a stick of PROBIOSTICK® during 30 days

Group Type EXPERIMENTAL

PROBIOSTICK® during 30 days

Intervention Type DIETARY_SUPPLEMENT

Every morning subjects will consume a stick of PROBIOSTICK® during 30 days

Interventions

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PROBIOSTICK® during 30 days

Every morning subjects will consume a stick of PROBIOSTICK® during 30 days

Intervention Type DIETARY_SUPPLEMENT

Placebo during 30 days

Every morning subjects will consume a stick of placebo during 30 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Rosell Lallemand

INDUSTRY

Sponsor Role lead

Responsible Party

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Biofortis

Locations

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Biofortis

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BIOSTRESS 11008

Identifier Type: -

Identifier Source: org_study_id

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