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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033799
First Posted: December 17, 2009
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
  Purpose
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 Sinusitis Otitis Bronchitis Pneumonia Influenza Gastroenteritis 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: Double (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®)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033799


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

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01033799     History of Changes
Other Study ID Numbers: NU207
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: January 20, 2017
Last Verified: January 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:
Infection
Communicable Diseases
Pneumonia
Otitis
Respiratory Tract Infections
Bronchitis
Gastroenteritis
Sinusitis
Pharyngitis
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