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

Primary Purpose

Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PROBIOSTICK® during 30 days
Placebo during 30 days
Sponsored by
Institut Rosell Lallemand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring PROBIOSTICK®, Probiotic, Anxiety, Daily stress

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biofortis

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

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

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

Outcomes

Primary Outcome Measures

SCL 90 questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2008
Last Updated
April 23, 2009
Sponsor
Institut Rosell Lallemand
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1. Study Identification

Unique Protocol Identification Number
NCT00807157
Brief Title
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Rosell Lallemand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress
Keywords
PROBIOSTICK®, Probiotic, Anxiety, Daily stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Every morning subjects will consume a stick of placebo during 30 days
Arm Title
1
Arm Type
Experimental
Arm Description
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
PROBIOSTICK® during 30 days
Intervention Description
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo during 30 days
Intervention Description
Every morning subjects will consume a stick of placebo during 30 days
Primary Outcome Measure Information:
Title
SCL 90 questionnaire
Time Frame
day 0 and day 30
Secondary Outcome Measure Information:
Title
Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement
Time Frame
day-14 ; day 0 and day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Biofortis
City
Nantes
ZIP/Postal Code
44200
Country
France

12. IPD Sharing Statement

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

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