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Lactobacillus Farciminis and Hyperalgesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852865
First Posted: February 27, 2009
Last Update Posted: May 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lallemand SAS
  Purpose
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 Intervention Phase
Inflammation Pain Drug: Lactobacillus farciminis Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lallemand SAS:

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

Enrollment: 48
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Henri DURAND, LALLEMAND SAS
ClinicalTrials.gov Identifier: NCT00852865     History of Changes
Other Study ID Numbers: HN 08-17
2008-A01380-55
First Submitted: February 25, 2009
First Posted: February 27, 2009
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