search
Back to results

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

Primary Purpose

Infectious Diseases, Healthy Subjects, Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Non fermented dairy product (control)
Sponsored by
Danone Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infectious Diseases focused on measuring 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.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harrisson Clinical Research Clinical Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control Product

Tested Product

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 16, 2009
Last Updated
January 18, 2017
Sponsor
Danone Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01033799
Brief Title
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Official Title
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat, Sinusitis, Otitis, Bronchitis, Pneumonia, Influenza, Gastroenteritis
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.

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Product
Arm Type
Sham Comparator
Arm Title
Tested Product
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Intervention Type
Other
Intervention Name(s)
Non fermented dairy product (control)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Harrisson Clinical Research Clinical Unit
City
München
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs