NCT00807157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 24, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

December 8, 2008

Last Update Submit

April 23, 2009

Conditions

AnxietyStress

Keywords

PROBIOSTICK®ProbioticAnxietyDaily stress

Outcome Measures

Primary Outcomes (1)

  • SCL 90 questionnaire

    day 0 and day 30

Secondary Outcomes (1)

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

    day-14 ; day 0 and day 30

Study Arms (2)

2

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo during 30 days

1

EXPERIMENTAL

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

Dietary Supplement: PROBIOSTICK® during 30 days

Interventions

PROBIOSTICK® during 30 daysDIETARY_SUPPLEMENT

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

1
Placebo during 30 daysDIETARY_SUPPLEMENT

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

2

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian healthy men or women
  • Age 30-60 years
  • Hospital anxiety and depression score equal or below 12 and above 4
  • Standard safety biology

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Nantes, 44200, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 11, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 24, 2009

Record last verified: 2009-04

Locations

FR(1)