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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat, Sinusitis, Otitis, Bronchitis, Pneumonia, Influenza, Gastroenteritis

Intervention / Treatment
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* Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
* Other: Non fermented dairy product (control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Product<br> | Other: Non fermented dairy product (control)<br> <br> |
| Active Comparator: Tested Product<br> | Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic - Lactobacillus casei DN114-001, dairy product - infections - shiftworkers, Common 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), and, gastrointestinal tract infection defined as gastroenteritis.