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NCT01033799 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01033799
Other study ID # NU207
Secondary ID
Status Completed
Phase N/A
First received December 16, 2009
Last updated January 18, 2017
Start date October 2006
Est. completion date August 2007

Study information
Verified date January 2017
Source Danone Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date August 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria: male and female aged 18-65 years; working in 2- or 3-shift work patterns (including night work); same job position for at least 4.5 months; a 19 to 30 kg/m2 body mass index; no symptoms of CIDs during the 2 weeks before product consumption; agreeing to a written informed consent.

Exclusion criteria: part time work (<90%); allergy/hypersensitivity to components of the study product; severe respiratory allergy; a situation which, in the investigator's opinion, could interfere with optimal participation or constitute a special risk for the volunteer; a history of chronic metabolic/gastro-intestinal disease (except appendectomy); surgery/intervention requiring general anesthesia in the last 4 weeks; administration of systemic/topical treatments likely to interfere with the evaluation parameters in the last 4 weeks; chronic disease requiring antibiotics/antiseptics/anti-inflammatory medications; special medicated diet; chronic/iatrogenic immunodeficiency; cardiac/renal/respiratory insufficiency; severe evolutive/chronic pathology; pregnancy, breast feeding or lacking effective contraception in females; susceptibility not to comply with dietary recommendation during the study period.

Study Design

Related Conditions & MeSH terms

Intervention

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

• Non fermented dairy product (control)

Locations
Country Name City State
Germany Harrisson Clinical Research Clinical Unit München

Sponsors (1)
Lead Sponsor Collaborator
Danone Research

Country where clinical trial is conducted

Germany, 

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