Back to resultsLactobacillus Farciminis and Hyperalgesia
Primary Purpose
Inflammation, Pain
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Lactobacillus farciminis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Inflammation, Pain
Eligibility Criteria
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- consumption of yogurts
Sites / Locations
- Cpc / Cic-Inserm 501
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
24 healthy volunteers consuming L.farciminis during three weeks
24 healthy volunteers consuming placebo during three weeks
Outcomes
Primary Outcome Measures
Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.
Secondary Outcome Measures
Measurement of cutaneous temperature of hyperalgesia areas
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00852865
Brief Title
Lactobacillus Farciminis and Hyperalgesia
Official Title
Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lallemand SAS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain
Keywords
Inflammation, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
24 healthy volunteers consuming L.farciminis during three weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
24 healthy volunteers consuming placebo during three weeks
Intervention Type
Drug
Intervention Name(s)
Lactobacillus farciminis
Intervention Description
1 capsule per day. Each capsule containing 4*109 CFU
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule per day
Primary Outcome Measure Information:
Title
Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.
Secondary Outcome Measure Information:
Title
Measurement of cutaneous temperature of hyperalgesia areas
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
consumption of yogurts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude DUBRAY, Professor
Organizational Affiliation
CPC/CIC-INSERM 501
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cpc / Cic-Inserm 501
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Lactobacillus Farciminis and Hyperalgesia
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