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OpenTrials
Completed

NCT Number: NCT00807157

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

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

Completed

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Stress

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis

Nantes, 44200, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROBIOSTICK® during 30 days

Dietary Supplement

Every morning subjects will consume a stick of PROBIOSTICK® during 30 days

Placebo during 30 days

Dietary Supplement

Every morning subjects will consume a stick of placebo during 30 days

Primary outcomes

  1. SCL 90 questionnaire

    Time frame: day 0 and day 30

Secondary outcomes

  1. Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement

    Time frame: day-14 ; day 0 and day 30

Sponsors and collaborators

Lead sponsor

Institut Rosell Lallemand

Industry

Registry information

Official study title

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

Acronym: BIOSTRESS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2008
Registry last updated
Apr 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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