Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress - Full Text View

Sponsored by:	Institut Rosell Lallemand
Information provided by:	Institut Rosell Lallemand
ClinicalTrials.gov Identifier:	NCT00807157

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

MedlinePlus related topics: Anxiety Dietary Supplements

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator 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
1: Experimental 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807157

Contacts

Contact: Béatrice baril

02 40 20 57 99

Locations

France
BIOFORTIS	Recruiting
Nantes, France, 44200
Contact: béatrice Baril 02 40 20 57 99 beatrice.baril@biofortis.fr
Principal Investigator: Jean Marc Cazaubiel, Doctor

Sponsors and Collaborators

Institut Rosell Lallemand

More Information

Responsible Party:	Biofortis ( Docteur Jean Marc Cazaubiel )
Study ID Numbers:	BIOSTRESS 11008
Study First Received:	December 8, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00807157
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Rosell Lallemand:

PROBIOSTICK®
Probiotic
Anxiety
Daily stress

Study placed in the following topic categories:

Stress
Healthy

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009