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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014