Text Size

Lactobacillus Farciminis and Hyperalgesia

This study has been completed.
Sponsor:
Information provided by:
Lallemand SAS
ClinicalTrials.gov Identifier:
NCT00852865
First received: February 25, 2009
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of cutaneous temperature of hyperalgesia areas [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • consumption of yogurts
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Henri DURAND, LALLEMAND SAS
ClinicalTrials.gov Identifier: NCT00852865     History of Changes
Other Study ID Numbers: HN 08-17, 2008-A01380-55
Study First Received: February 25, 2009
Last Updated: April 30, 2009
Health Authority: France: Direction Générale de la Santé

Keywords provided by Lallemand SAS:
Inflammation
Pain

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

ClinicalTrials.gov processed this record on May 23, 2013