NCT01033799

Brief Summary

This single-center, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on immune functions in healthy shift workers. Volunteers received either 200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a 1-month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable

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

October 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

December 16, 2009

Last Update Submit

January 18, 2017

Conditions

Infectious DiseasesHealthy SubjectsRespiratory Tract InfectionsSore ThroatSinusitisOtitisBronchitisPneumoniaInfluenzaGastroenteritis

Keywords

Probiotic - Lactobacillus casei DN114-001dairy product - infections - shiftworkersCommon infectious diseases,occuring in healthy subjects,including upper respiratory tract infections (defined as rhinopharyngitis, sore throat, sinusitis and otitis),lower respiratory tract infections (defined as bronchitis,pneumopathy and flu and flu-like syndromes), andgastrointestinal tract infection defined as gastroenteritis.

Study Arms (2)

Control Product

SHAM COMPARATOR
Other: Non fermented dairy product (control)

Tested Product

ACTIVE COMPARATOR
Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

Interventions

Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)OTHER
Tested Product
Non fermented dairy product (control)OTHER
Control Product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harrisson Clinical Research Clinical Unit

München, 80636, Germany

Location

MeSH Terms

Conditions

Communicable DiseasesRespiratory Tract InfectionsPharyngitisSinusitisOtitisBronchitisPneumoniaInfluenza, HumanGastroenteritisLung Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesNose DiseasesEar DiseasesBronchial DiseasesLung Diseases, ObstructiveOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Study Completion

August 1, 2007

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

DE(1)