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

Infectious Episodes (ENT, Gastro-intestinal and Pulmonary) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796393
• Other study ID #: 10308
• Secondary ID: 2008-A01187-48
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: June 22, 2011
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Institut Rosell Lallemand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)

Intervention

Dietary Supplement:
• Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
1 pill per day for 12 weeks
• Starch of potato
1 pill per day for 12 weeks

Locations

Country	Name	City	State
France	Biofortis	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Institut Rosell Lallemand	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infectious episodes		During the study	No