Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes - Full Text View

Sponsors and Collaborators:	Universiteit Antwerpen Yakult Honscha
Information provided by:	Universiteit Antwerpen
ClinicalTrials.gov Identifier:	NCT00849277

Purpose

The purpose of this study is to determine whether probiotic treatment improves the protection against respiratory infections after influenza vaccination in elderly living in nursing homes.

Condition	Intervention	Phase
Respiratory Tract Infections	Drug: Lactobacillus casei Shirota	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Flu Nursing Homes

Drug Information available for: Lactobacillus casei

U.S. FDA Resources

Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:

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 ]

Enrollment:	737
Study Start Date:	October 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Trial endpoints:

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy male and female volunteers of 65 years or older
volunteers reside in residential homes
volunteers must be willing to swallow Yakult/placebo 2x/day for 3 weeks prevaccination and 5 months follow-up
participants must be able to comply with requirements of study (e.g. assessment of respiratory symptoms, Yakult/placebo administration)
participants must read and sign written Informed Consent Form after the nature of the study has been fully explained

Exclusion Criteria:

elderly with:

any medical or practical condition which make the volunteer not suitable for participating in this study at discretion of the investigator
any current relevant infectious disease
any current known disorder having negative repercussions on the volunteer's immune system, such as auto-immune diseases, COPD requiring oxigen, cancer, chronic inflammatory disease
allergy to influenza vaccine, eggs, neomycin, amphotericin B, erythromycin, amantadine
ongoing treatment with immunosuppressive drugs, chemotherapeutics or other antineoplastic medication
current use of antibiotics or use 6 weeks prior to study entry
use of any investigative drug (other drugs who are also under investigation) within 90 days prior to study entry
with markedly abnormal results in any of the screening laboratory tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849277

Locations

Belgium
University of Antwerp
Antwerp, Belgium, 2610

Sponsors and Collaborators

Universiteit Antwerpen

Yakult Honscha

More Information

No publications provided

Responsible Party:	University of Antwerp ( Van Puyenbroeck Karolien )
Study ID Numbers:	2414
Study First Received:	February 20, 2009
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00849277 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Universiteit Antwerpen:

Respiratory Tract Infections
Influenza, Human
Probiotics

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Acidophilus
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Orthomyxoviridae Infections
Infection

ClinicalTrials.gov processed this record on August 30, 2009