- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00852865
Lactobacillus Farciminis and Hyperalgesia
April 30, 2009 updated by: Lallemand SAS
Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation
We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation.
A comparaison of results before and after three weeks of treatment will be made.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Cpc / Cic-Inserm 501
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- consumption of yogurts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
24 healthy volunteers consuming L.farciminis during three weeks
|
1 capsule per day.
Each capsule containing 4*109 CFU
|
PLACEBO_COMPARATOR: 2
24 healthy volunteers consuming placebo during three weeks
|
1 capsule per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.
|
Secondary Outcome Measures
Outcome Measure |
---|
Measurement of cutaneous temperature of hyperalgesia areas
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claude DUBRAY, Professor, CPC/CIC-INSERM 501
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
April 1, 2009
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 26, 2009
First Posted (ESTIMATE)
February 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
May 1, 2009
Last Update Submitted That Met QC Criteria
April 30, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN 08-17
- 2008-A01380-55
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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