Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes
|ClinicalTrials.gov Identifier: NCT00849277|
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : February 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections||Drug: Lactobacillus casei Shirota||Phase 4|
Influenza virus is a member of the orthomyxovirus family and causes an acute viral disease of the respiratory tract. The illness is usually self-limiting. Hospitalization and deaths mainly occur in high-risk groups (elderly, chronically ill). Response to vaccination is subject to high levels of variability due to age, stress, nutritional stage, etc.
Lactic acid bacteria are naturally commensal bacteria in the small and large intestines. These bacteria protect the host against potential pathogens by competitive exclusion and also by the production of antibacterial agents known as bacteriocins. It has only been recently shown that another mechanism whereby probiotic bacteria may provide a health benefit is by modulating immune responses.
Lactobacillus casei strain Shirota (LcS) is widely consumed in fermented milk products. Several studies, in animals as wells as in humans, report on the immunomodulatory functions of LcS.
The aim of this multicentre, randomized, placebo controlled, double blind study (RCT) is to assess if probiotic treatment with Lactobacillus casei Shirota improves the protection against influenza(-like) infections after vaccination with trivalent influenza vaccine in elderly residing in nursing homes.
- Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
- Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||737 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An RCT in Nursing Homes: the Effect of a Probiotic Treatment With Lactobacillus Casei Shirota on Respiratory Morbidity After Influenza Vaccination of Elderly.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
- Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness) [ Time Frame: during 5 months ]
- Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment [ Time Frame: 4 weeks after vaccination ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849277
|University of Antwerp|
|Antwerp, Belgium, 2610|