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

This study has been completed.
Sponsor:
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01033799
First received: December 16, 2009
Last updated: June 21, 2011
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers

Resource links provided by NLM:


Further study details as provided by Danone Research:

Study Start Date: October 2006
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033799

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

No publications provided

Responsible Party: DR. STEPHAN DE LA MOTTE, HARRISSON CLINICAL RESEARCH CLINICAL UNIT
ClinicalTrials.gov Identifier: NCT01033799     History of Changes
Other Study ID Numbers: NU207
Study First Received: December 16, 2009
Last Updated: June 21, 2011
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

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:
Bronchitis
Communicable Diseases
Infection
Gastroenteritis
Influenza, Human
Otitis
Pharyngitis
Pneumonia
Respiratory Tract Infections
Sinusitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Gastrointestinal Diseases
Digestive System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on April 17, 2014