Status:
COMPLETED
Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
Yakult Honsha Co., LTD
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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.
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 hi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
737 Patients enrolled
Trial Details
Trial ID
NCT00849277
Start Date
October 1 2006
End Date
April 1 2008
Last Update
February 23 2009
Active Locations (1)
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1
University of Antwerp
Antwerp, Antwerp, Belgium, 2610