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

Danone logo

Danone

Status

Completed

Conditions

Influenza
Healthy Subjects
Infectious Diseases
Otitis
Sore Throat
Gastroenteritis
Bronchitis
Pneumonia
Respiratory Tract Infections
Sinusitis

Treatments

Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Other: Non fermented dairy product (control)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033799
NU207

Details and patient eligibility

About

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.

Enrollment

1,000 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,000 participants in 2 patient groups

Control Product
Sham Comparator group
Treatment:
Other: Non fermented dairy product (control)
Tested Product
Active Comparator group
Treatment:
Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems