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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315418
Recruitment Status : Terminated
First Posted : March 15, 2011
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):
Danone Research

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Study Start Date : December 2006
Primary Completion Date : May 2007
Study Completion Date : July 2007

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01315418

Médecin-chef du Groupement Formation Instruction
Villeneuve Saint-Georges, France, 94190
Sponsors and Collaborators
Danone Research

Responsible Party: Danone Research Identifier: NCT01315418     History of Changes
Other Study ID Numbers: NU201
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Danone Research:
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:
Communicable Diseases
Respiratory Tract Infections
Lung Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Gastrointestinal Diseases
Digestive System Diseases
Paranasal Sinus Diseases
Nose Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Nasopharyngeal Diseases