NCT00849277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
Last Updated

February 23, 2009

Status Verified

February 1, 2009

Enrollment Period

1.5 years

First QC Date

February 20, 2009

Last Update Submit

February 20, 2009

Conditions

Respiratory Tract Infections

Keywords

Respiratory Tract InfectionsInfluenza, HumanProbiotics

Outcome Measures

Primary Outcomes (2)

  • Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)

    during 5 months

  • Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment

    4 weeks after vaccination

Interventions

Lactobacillus casei ShirotaDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Antwerp

Antwerp, Antwerp, 2610, Belgium

Location

Related Publications (1)

  • Van Puyenbroeck K, Hens N, Coenen S, Michiels B, Beunckens C, Molenberghs G, Van Royen P, Verhoeven V. Efficacy of daily intake of Lactobacillus casei Shirota on respiratory symptoms and influenza vaccination immune response: a randomized, double-blind, placebo-controlled trial in healthy elderly nursing home residents. Am J Clin Nutr. 2012 May;95(5):1165-71. doi: 10.3945/ajcn.111.026831. Epub 2012 Mar 21.

    PMID: 22440853DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsInfluenza, Human

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

October 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 23, 2009

Record last verified: 2009-02

Locations

BE(1)