AnxietyBIOSTRESSNCT00807157
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
A study testing PROBIOSTICK® during 30 days in people with Anxiety and Stress, run by Institut Rosell Lallemand at 1 site in France.
Trial summary
The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- What is being tested?
- PROBIOSTICK® during 30 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian healthy men or women
- Age 30-60 years
- Hospital anxiety and depression score equal or below 12 and above 4
- Standard safety biology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.
- Being tested
- PROBIOSTICK® during 30 days, Placebo during 30 days
- Keywords
- PROBIOSTICK®, Probiotic, Anxiety, Daily stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROBIOSTICK® during 30 daysDietary supplement
Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
Placebo during 30 daysDietary supplement
Every morning subjects will consume a stick of placebo during 30 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Every morning subjects will consume a stick of placebo during 30 days Receives: Dietary Supplement: Placebo during 30 days |
| 1 | Experimental | Every morning subjects will consume a stick of PROBIOSTICK® during 30 days Receives: Dietary Supplement: PROBIOSTICK® during 30 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCL 90 questionnaire
Measured: day 0 and day 30
Secondary outcomes (1)
Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement
Measured: day-14 ; day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Rosell Lallemand
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807157
- Sponsor's protocol ID
- BIOSTRESS 11008
- Acronym
- BIOSTRESS
- Status last verified
- Apr 2009
- First submitted
- 8 Dec 2008
- Last updated
- 24 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00807157
- Acronym / sponsor ID
- BIOSTRESS / BIOSTRESS 11008
- Keywords
- PROBIOSTICK®, Probiotic, Anxiety, Daily stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Institut Rosell LallemandIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Dietary Supplement: Placebo during 30 daysEvery morning subjects will consume a stick of placebo during 30 days |
| 1 | Experimental | Dietary Supplement: PROBIOSTICK® during 30 daysEvery morning subjects will consume a stick of PROBIOSTICK® during 30 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caucasian healthy men or women
- Age 30-60 years
- Hospital anxiety and depression score equal or below 12 and above 4
- Standard safety biology
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROBIOSTICK® during 30 daysEvery morning subjects will consume a stick of PROBIOSTICK® during 30 days | Dietary supplement | 1 |
| Placebo during 30 daysEvery morning subjects will consume a stick of placebo during 30 days | Dietary supplement | 2 |
Primary outcome
SCL 90 questionnaire
Time frame: day 0 and day 30
1 secondary outcome
Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement
Time frame: day-14 ; day 0 and day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROBIOSTICK® during 30 days in people with Anxiety and Stress, run by Institut Rosell Lallemand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCL 90 questionnaire (time frame: day 0 and day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2009.