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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universiteit Antwerpen
• Collaborator: Yakult Honsha Co., LTD

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