Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

Overview

This multicentric, 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 the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Basic Science
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: May 2007

Interventions

• Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
• Other: 2-Non fermented dairy product (control)

Arms, Groups and Cohorts

• Active Comparator: 1 = Tested product
• Sham Comparator: 2 = Control product

Participating in This Clinical Trial

Inclusion Criteria

• male and female aged 18-29 years – attending 7 weeks of firemen training school – a 19 to 29 kg/m2 body mass index – found medically healthy (in particular, free of respiratory and GI tract symptoms) – agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour. Exclusion Criteria:

• Subject who is not reading and writing French, or not understanding informed consent or study protocol – subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy; – subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes…) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease…) – subject having experienced any infectious disease during the last 7 days – subject with current diarrhoea or constipation – subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study – subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study – subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation…) or with eating disorders (anorexia, bulimia, alcoholism…) – subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment… – subject already enrolled in another clinical study, or currently under an exemption period from a previous study – female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study – subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Danone Research
• Provider of Information About this Clinical Study
  • Sponsor