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

April 23, 2009 updated by: Institut Rosell Lallemand

Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44200
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Every morning subjects will consume a stick of placebo during 30 days
Dietary supplement: Placebo during 30 days
Every morning subjects will consume a stick of placebo during 30 days
Experimental: 1
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
Dietary supplement: PROBIOSTICK® during 30 days
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCL 90 questionnaire
Time Frame: day 0 and day 30
day 0 and day 30

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Rosell Lallemand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2009

Last Update Submitted That Met QC Criteria

April 23, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOSTRESS 11008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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