NCT00852865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

2 months

First QC Date

February 25, 2009

Last Update Submit

April 30, 2009

Conditions

InflammationPain

Keywords

InflammationPain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Measurement of cutaneous temperature of hyperalgesia areas

Study Arms (2)

1

EXPERIMENTAL

24 healthy volunteers consuming L.farciminis during three weeks

Drug: Lactobacillus farciminis

2

PLACEBO COMPARATOR

24 healthy volunteers consuming placebo during three weeks

Drug: Placebo

Interventions

Lactobacillus farciminisDRUG

1 capsule per day. Each capsule containing 4\*109 CFU

1
PlaceboDRUG

1 capsule per day

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • consumption of yogurts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cpc / Cic-Inserm 501

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

InflammationPain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Claude DUBRAY, Professor

    CPC/CIC-INSERM 501

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 27, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

FR(1)