Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
June 22, 2011 updated by: Institut Rosell Lallemand
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nantes, France
- Biofortis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
Subject with active product, not vaccinated against influenza.
|
1 pill per day for 12 weeks
|
|
Placebo Comparator: 3
Subject with placebo, vaccinated against influenza.
|
1 pill per day for 12 weeks
|
|
Placebo Comparator: 4
Subject with placebo, not vaccinated against influenza.
|
1 pill per day for 12 weeks
|
|
Experimental: 1
Subject with active product, vaccinated against influenza
|
1 pill per day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of infectious episodes
Time Frame: During the study
|
During the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean Marc Cazaubiel, Dr, Biofortis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
November 21, 2008
First Submitted That Met QC Criteria
November 21, 2008
First Posted (Estimate)
November 24, 2008
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10308
- 2008-A01187-48
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.