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

NCT ID: NCT00796393

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Subject with active product, not vaccinated against influenza.

Group Type EXPERIMENTAL

Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033

Intervention Type DIETARY_SUPPLEMENT

1 pill per day for 12 weeks

3

Subject with placebo, vaccinated against influenza.

Group Type PLACEBO_COMPARATOR

Starch of potato

Intervention Type DIETARY_SUPPLEMENT

1 pill per day for 12 weeks

4

Subject with placebo, not vaccinated against influenza.

Group Type PLACEBO_COMPARATOR

Starch of potato

Intervention Type DIETARY_SUPPLEMENT

1 pill per day for 12 weeks

1

Subject with active product, vaccinated against influenza

Group Type EXPERIMENTAL

Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033

Intervention Type DIETARY_SUPPLEMENT

1 pill per day for 12 weeks

Interventions

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Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033

1 pill per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Starch of potato

1 pill per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioFortis

OTHER

Sponsor Role collaborator

Institut Rosell Lallemand

INDUSTRY

Sponsor Role lead

Responsible Party

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Institut Rosell Lallemand

Principal Investigators

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Jean Marc Cazaubiel, Dr

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

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Biofortis

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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2008-A01187-48

Identifier Type: -

Identifier Source: secondary_id

10308

Identifier Type: -

Identifier Source: org_study_id

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