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

This study has been completed.
Information provided by (Responsible Party):
Danone Research Identifier:
First received: December 16, 2009
Last updated: January 18, 2017
Last verified: January 2017
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.

Condition Intervention
Infectious Diseases
Healthy Subjects
Respiratory Tract Infections
Sore Throat
Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Other: Non fermented dairy product (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers

Further study details as provided by Danone Research:

Enrollment: 1000
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Product Other: Non fermented dairy product (control)
Active Comparator: Tested Product Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

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Please refer to this study by its identifier: NCT01033799

Harrisson Clinical Research Clinical Unit
München, Germany, 80636
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research Identifier: NCT01033799     History of Changes
Other Study ID Numbers: NU207
Study First Received: December 16, 2009
Last Updated: January 18, 2017

Keywords provided by Danone Research:
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.

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Gastrointestinal Diseases
Digestive System Diseases
Paranasal Sinus Diseases
Nose Diseases
Pharyngeal Diseases
Stomatognathic Diseases processed this record on May 25, 2017