Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 14, 2011
May 3, 2011
December 2006
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01315418 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Basic Science
  • 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)
  • Active Comparator: 1 = Tested product
    Intervention: Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
  • Sham Comparator: 2 = Control product
    Intervention: Other: 2-Non fermented dairy product (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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
Both
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01315418
NU201
No
Not Provided
Danone Research
Dr Cédric ERNOUF
Not Provided
Danone Research
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP