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Lactobacillus Farciminis and Hyperalgesia

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ClinicalTrials.gov Identifier: NCT00852865
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:
Lallemand SAS

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.

Condition or disease Intervention/treatment Phase
Inflammation Pain Drug: Lactobacillus farciminis Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation
Study Start Date : February 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
24 healthy volunteers consuming L.farciminis during three weeks
Drug: Lactobacillus farciminis
1 capsule per day. Each capsule containing 4*109 CFU
Placebo Comparator: 2
24 healthy volunteers consuming placebo during three weeks
Drug: Placebo
1 capsule per day



Primary Outcome Measures :
  1. Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.

Secondary Outcome Measures :
  1. Measurement of cutaneous temperature of hyperalgesia areas


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • consumption of yogurts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852865


Locations
France
Cpc / Cic-Inserm 501
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Lallemand SAS
Investigators
Principal Investigator: Claude DUBRAY, Professor CPC/CIC-INSERM 501

Responsible Party: Henri DURAND, LALLEMAND SAS
ClinicalTrials.gov Identifier: NCT00852865     History of Changes
Other Study ID Numbers: HN 08-17
2008-A01380-55
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by Lallemand SAS:
Inflammation
Pain

Additional relevant MeSH terms:
Inflammation
Hyperalgesia
Pathologic Processes
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms