Bronchitis, Gastroenteritis, Healthy Subjects, Infectious Diseases, Influenza, Otitis, Pneumonia, Respiratory Tract Infections, Sinusitis, Sore Throat
Conditions
Keywords
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.
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.
Interventions
OTHERFermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
OTHERNon fermented dairy product (control)
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Countries
Germany
Outcome results
None listed