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

This study has been completed.
Sponsor:
Information provided by:
Institut Rosell Lallemand
ClinicalTrials.gov Identifier:
NCT00807157
First received: December 8, 2008
Last updated: April 23, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention
Anxiety
Stress
 Dietary Supplement: PROBIOSTICK® during 30 days
Dietary Supplement: Placebo during 30 days

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Institut Rosell Lallemand:

Primary Outcome Measures:
  • SCL 90 questionnaire [ Time Frame: day 0 and day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement [ Time Frame: day-14 ; day 0 and day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807157

Locations
France
Biofortis
Nantes, France, 44200
Sponsors and Collaborators
Institut Rosell Lallemand
  More Information

No publications provided

Responsible Party: Docteur Jean Marc Cazaubiel, Biofortis
ClinicalTrials.gov Identifier: NCT00807157     History of Changes
Other Study ID Numbers: BIOSTRESS 11008
Study First Received: December 8, 2008
Last Updated: April 23, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Rosell Lallemand:
PROBIOSTICK®
Probiotic
Anxiety
Daily stress

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013