Lactobacillus Farciminis and Hyperalgesia | NCT00852865

Studies
Lactobacillus Farciminis and Hyperalgesia

NCT00852865

Sponsor

Lallemand SAS

Status

Completed

Last Update Posted

May 1, 2009Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Inflammation
Pain

Interventions

Lactobacillus farciminis
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-A01380-55

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Feb 25, 2009

First Submission Date that Met QC Criteria

Feb 26, 2009

First Posted Date

Feb 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2009

Last Update Posted Date

May 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus farciminis	Drug	1 capsule per day. Each capsule containing 4*109 CFU	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Measurement of cutaneous temperature of hyperalgesia areas

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

consumption of yogurts

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claude DUBRAY, Professor	CPC/CIC-INSERM 501	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cpc / Cic-Inserm 501		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D010146	Pain

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided