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

Anxiety Clinical Trial

— BIOSTRESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807157
• Other study ID #: BIOSTRESS 11008
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: April 23, 2009
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Institut Rosell Lallemand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Dietary Supplement:
• PROBIOSTICK® during 30 days
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
• Placebo during 30 days
Every morning subjects will consume a stick of placebo during 30 days

Locations

Country	Name	City	State
France	Biofortis	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Rosell Lallemand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCL 90 questionnaire		day 0 and day 30	Yes
Secondary	Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement		day-14 ; day 0 and day 30	Yes