Lactobacillus Farciminis and Hyperalgesia

• Sponsor: Lallemand SAS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00852865
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 24.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Pain	Drug: Lactobacillus farciminis; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• 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: Feb 1, 2009
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• consumption of yogurts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cpc / Cic-Inserm 501	Clermont-Ferrand		France	63000

Sponsors and Collaborators

• Lallemand SAS

Investigators

• Principal Investigator: Claude DUBRAY, Professor, CPC/CIC-INSERM 501

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00852865
• Other Study ID Numbers: HN 08-17; 2008-A01380-55
• First Posted: Feb 27, 2009
• Last Update Posted: May 1, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: Inflammation; Pain
• Additional relevant MeSH terms: Hyperalgesia; Inflammation

Study Results

No Results Posted as of May 1, 2009