NCT00796393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

November 21, 2008

Last Update Submit

June 22, 2011

Conditions

Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)

Outcome Measures

Primary Outcomes (1)

  • Number of infectious episodes

    During the study

Study Arms (4)

2

EXPERIMENTAL

Subject with active product, not vaccinated against influenza.

Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033

3

PLACEBO COMPARATOR

Subject with placebo, vaccinated against influenza.

Dietary Supplement: Starch of potato

4

PLACEBO COMPARATOR

Subject with placebo, not vaccinated against influenza.

Dietary Supplement: Starch of potato

1

EXPERIMENTAL

Subject with active product, vaccinated against influenza

Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033

Interventions

Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033DIETARY_SUPPLEMENT

1 pill per day for 12 weeks

12
Starch of potatoDIETARY_SUPPLEMENT

1 pill per day for 12 weeks

34

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who accept not to alter their food habits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Nantes, France

Location

Study Officials

  • Jean Marc Cazaubiel, Dr

    BioFortis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

FR(1)