Influenza Clinical Trial
Official title:
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Verified date | January 2017 |
Source | Danone Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Harrisson Clinical Research Clinical Unit | München |
Lead Sponsor | Collaborator |
---|---|
Danone Research |
Germany,
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