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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00807157 |
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Date of registration:
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08/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
BIOSTRESS |
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Scientific title:
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Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00807157 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety
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Stress
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Intervention(s)
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Dietary Supplement: Placebo during 30 days
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Dietary Supplement: PROBIOSTICK® during 30 days
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Primary Outcome(s)
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SCL 90 questionnaire
[Time Frame: day 0 and day 30]
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Secondary Outcome(s)
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Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement
[Time Frame: day-14 ; day 0 and day 30]
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Secondary ID(s)
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BIOSTRESS 11008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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