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
  Purpose

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 Intervention
Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)
Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
Dietary Supplement: Starch of potato

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Institut Rosell Lallemand:

Primary Outcome Measures:
  • Number of infectious episodes [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00796393

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

No publications provided

Responsible Party: Henri Durand, Institut Rosell Lallemand
ClinicalTrials.gov Identifier: NCT00796393     History of Changes
Other Study ID Numbers: 10308, 2008-A01187-48
Study First Received: November 21, 2008
Last Updated: June 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on July 24, 2014