Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers

Not Applicable

Completed

• Conditions: Infectious Diseases; Gastroenteritis; Healthy Subjects; Sore Throat; Pneumonia; Influenza; Sinusitis; Otitis; Respiratory Tract Infections; Bronchitis
• Interventions: Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®); Other: Non fermented dairy product (control)

• Registration Number: NCT01033799
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-04
• Study Completion: 2007-08
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Trial Locations

Locations (1)

Harrisson Clinical Research Clinical Unit; 🇩🇪 München, Germany