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

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.

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

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.

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