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

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 Overview

• Status: Terminated
• Conditions: Gastroenteritis; Sinusitis; Otitis; Bronchitis; Upper Respiratory Tract Infections; Sore Throat; Flu; Lower Respiratory Tract Infections; Rhinopharyngitis; Pneumopathy; Flu-like Syndromes
• Intervention / Treatment: Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®); Other: 2-Non fermented dairy product (control)

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeneuve Saint-Georges, France, 94190
    • Médecin-chef du Groupement Formation Instruction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 = Tested product	Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Sham Comparator: 2 = Control product	Other: 2-Non fermented dairy product (control)

Collaborators and Investigators

• Sponsor: Danone Research

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Probiotic - Lactobacillus casei DN-114 001 - dairy product -; infections - firemen; 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); gastrointestinal tract infection defined as gastroenteritis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Gastrointestinal Diseases; Bronchial Diseases; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Lung Diseases, Obstructive; Paranasal Sinus Diseases; Nose Diseases; Lung Diseases; Infections; Communicable Diseases; Sinusitis; Otitis; Gastroenteritis; Respiratory Tract Infections; Bronchitis; Pharyngitis; Nasopharyngitis
• Other Study ID Numbers: NU201