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Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849277
First Posted: February 23, 2009
Last Update Posted: February 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yakult Honsha Co., LTD
Information provided by:
Universiteit Antwerpen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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:


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:

  1. Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
  2. Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849277


Locations
Belgium
University of Antwerp
Antwerp, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen
Yakult Honsha Co., LTD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Van Puyenbroeck Karolien, University of Antwerp
ClinicalTrials.gov Identifier: NCT00849277     History of Changes
Other Study ID Numbers: 2414
First Submitted: February 20, 2009
First Posted: February 23, 2009
Last Update Posted: February 23, 2009
Last Verified: February 2009

Keywords provided by Universiteit Antwerpen:
Respiratory Tract Infections
Influenza, Human
Probiotics

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection