Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.

This study has been completed.
Sponsor:
Collaborator:
BioFortis
Information provided by:
Institut Rosell Lallemand
ClinicalTrials.gov Identifier:
NCT00796393
First received: November 21, 2008
Last updated: June 22, 2011
Last verified: June 2011

November 21, 2008
June 22, 2011
November 2008
April 2010   (final data collection date for primary outcome measure)
Number of infectious episodes [ Time Frame: During the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.

We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)
  • Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
    1 pill per day for 12 weeks
  • Dietary Supplement: Starch of potato
    1 pill per day for 12 weeks
  • Experimental: 2
    Subject with active product, not vaccinated against influenza.
    Intervention: Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
  • Placebo Comparator: 3
    Subject with placebo, vaccinated against influenza.
    Intervention: Dietary Supplement: Starch of potato
  • Placebo Comparator: 4
    Subject with placebo, not vaccinated against influenza.
    Intervention: Dietary Supplement: Starch of potato
  • Experimental: 1
    Subject with active product, vaccinated against influenza
    Intervention: Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who accept not to alter their food habits

Exclusion Criteria:

  • Food allergy
  • Regular consumption of probiotics
  • Diabetes
  • Respiratory deficiency
  • Cardiac deficiency
  • Cancer or chronicle disease not stabilized
  • Splenectomy, sickle-cell anemia
  • Immuno depression or immunodeficiency acquired or congenital
  • Immuno depressor or corticoid treatments
Both
60 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00796393
10308, 2008-A01187-48
No
Henri Durand, Institut Rosell Lallemand
Institut Rosell Lallemand
BioFortis
Principal Investigator: Jean Marc Cazaubiel, Dr BioFortis
Institut Rosell Lallemand
June 2011

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