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NCT00852865 Clinical Trial

Lactobacillus Farciminis and Hyperalgesia

Pain Clinical Trial

Official title:
Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00852865
Other study ID # HN 08-17
Secondary ID 2008-A01380-55
Status Completed
Phase Phase 1
First received February 25, 2009
Last updated April 30, 2009
Start date February 2009
Est. completion date April 2009

Study information
Verified date April 2009
Source Lallemand SAS
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

- consumption of yogurts

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lactobacillus farciminis
1 capsule per day. Each capsule containing 4*109 CFU
• Placebo
1 capsule per day

Locations
Country Name City State
France Cpc / Cic-Inserm 501 Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
Lallemand SAS

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus. No
Secondary Measurement of cutaneous temperature of hyperalgesia areas No
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