Lactobacillus Farciminis and Hyperalgesia

April 30, 2009 updated by: Lallemand SAS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Cpc / Cic-Inserm 501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • consumption of yogurts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.

Secondary Outcome Measures

Outcome Measure
Measurement of cutaneous temperature of hyperalgesia areas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lallemand SAS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (ESTIMATE)

February 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN 08-17
  • 2008-A01380-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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