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

This study has been terminated.
Sponsor:
Collaborator:
Dr Cédric ERNOUF
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01315418
First received: March 14, 2011
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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 Intervention
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
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

Resource links provided by NLM:


Further study details as provided by Danone Research:

Study Start Date: December 2006
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315418

Locations
France
Médecin-chef du Groupement Formation Instruction
Villeneuve Saint-Georges, France, 94190
Sponsors and Collaborators
Danone Research
Dr Cédric ERNOUF
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01315418     History of Changes
Other Study ID Numbers: NU201
Study First Received: March 14, 2011
Last Updated: May 3, 2011
Health Authority: France: AFSSAPS

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:
Bronchitis
Communicable Diseases
Gastroenteritis
Infection
Lung Diseases
Nasopharyngitis
Pharyngitis
Respiratory Tract Infections
Sinusitis
Syndrome
Bronchial Diseases
Digestive System Diseases
Disease
Gastrointestinal Diseases
Lung Diseases, Obstructive
Nasopharyngeal Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Pharyngeal Diseases
Respiratory Tract Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014