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

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ClinicalTrials.gov Identifier: NCT00796393
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
BioFortis
Information provided by:
Institut Rosell Lallemand

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infectious Episodes (ENT, Gastro-intestinal and Pulmonary) Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 Dietary Supplement: Starch of potato Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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.
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 2
Subject with active product, not vaccinated against influenza.
Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
1 pill per day for 12 weeks
Placebo Comparator: 3
Subject with placebo, vaccinated against influenza.
Dietary Supplement: Starch of potato
1 pill per day for 12 weeks
Placebo Comparator: 4
Subject with placebo, not vaccinated against influenza.
Dietary Supplement: Starch of potato
1 pill per day for 12 weeks
Experimental: 1
Subject with active product, vaccinated against influenza
Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
1 pill per day for 12 weeks



Primary Outcome Measures :
  1. Number of infectious episodes [ Time Frame: During the study ]


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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00796393


Locations
France
Biofortis
Nantes, France
Sponsors and Collaborators
Institut Rosell Lallemand
BioFortis
Investigators
Principal Investigator: Jean Marc Cazaubiel, Dr BioFortis

Responsible Party: Henri Durand, Institut Rosell Lallemand
ClinicalTrials.gov Identifier: NCT00796393     History of Changes
Other Study ID Numbers: 10308
2008-A01187-48
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Communicable Diseases
Infection