Trial document





This trial has been registered retrospectively.
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  DRKS00003958

Trial Description

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Title

A Multicenter Randomized, Controlled Clinical Study on the Effect of a Probiotic (Lactobacillus casei Shirota) on the Immune Response to Influenza Vaccination

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Higher vaccination responses are generally accepted as beneficial, and several studies documented that certain probiotics enhance antibody response to influenza vaccination. The study is to investigate whether the intake of probiotic product containing Lactobacillus casei Shirota may enhance the immune response of vaccination in healthy subjects.

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Brief Summary in Scientific Language

The aim of this study is to investigate, if the regular consumption of a probiotic drink containing L. casei Shirota enhances antibody response to influenza vaccination for clarifying whether this strain may enable enhancement of immunity against influenza. A second aim is to investigate, whether if the regular consumption of a probiotic drink containing L. casei Shirota enhances seroprotection rate and / or seroconversion rate.

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Organizational Data

  •   DRKS00003958
  •   2012/06/21
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  •   no
  •   Approved
  •   150/11 (l), Ethikkommission der Ärztekammer Schleswig-Holstein (Ethik-Kommission I)
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Secondary IDs

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Health Condition or Problem studied

  •   Enhancement of influenza vaccination effect
  •   J10 -  Influenza due to other identified influenza virus
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Interventions/Observational Groups

  •   Active comparator: fermented dairy drink. Subjects consume fermented dairy drink Yakult containing Lactobacillus casei Shirota daily for 7 weeks (1.3x10^10 CFU per day). 4 weeks after start of consumption, influenza vaccine is administrated.
  •   Control comparator: Placebo. Subjects consume non-fermented dairy drink without Lactobacillus casei Shirota daily for 7 weeks. 4 weeks after start of consumption, influenza vaccine is administrated.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Geometric mean titre (GMT) of antibodies against one of the 3 influenza strains in HI test 3 weeks after vaccination

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Secondary Outcome

1.Geometric mean fold increase (GMFI = geometric mean of titre folds increases)
between baseline (before start of consumption) and 3 weeks after vaccination;
2.Seroprotection rate (defined as percentage of subjects attaining an antibody titre ≥ 40
in HI test);
3.Seroconversion rate (defined as percentage of subjects with at least 4-fold increase in
antibody titres in HI test).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2011/12/29
  •   626
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

● Free-living adults aged ≥ 50 years willing to have influenza vaccination season 2011/2012
● willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products
● written informed consent

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Exclusion Criteria

● Subjects enrolled in another clinical study in the last 4 weeks
● Subjects already vaccinated against influenza during 2011-2012 with either the influenza vaccine used in the present study or another influenza vaccine.
● Subjects previously vaccinated against influenza during 2010-2011
● Subjects previously vaccinated against pandemic influenza in 2009 or 2010 with an influenza pandemic vaccine (A/H1N1)
● known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
● active autoimmune diseases
● allergy or hypersensitivity to any component of the vaccine (e. g. chicken egg protein, certain antibiotics)
● allergy or hypersensitivity to any component of the test product (e.g. milk protein)
● suffering from influenza or influenza-like illness in the current winter season (since Nov. 2011)
● symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion.
● severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, respiratory insufficiency)
● chronic abdominal pain
● systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, antirheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases
● other treatments likely to interfere with study outcome (e.g. laxatives, body weight management and/or medication)
● lactose intolerance
● diabetes mellitus on drug therapy
● severe neurological, cognitive or psychiatric diseases
● surgery or intervention requiring general anaesthesia within 2 months before the study
● pregnancy or lactation
● eating disorders or special diets (e.g. vegan)
● alcohol and products abuse
● legal incapacity

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Addresses

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    • Yakult Honsha Co., Ltd.
    • 1-19, Higashi-Shinbashi 1-chome, Minato-ku
    • 105-8660  Tokyo
    • Japan
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    • Clinical Research Center Kiel GmbH
    • Ms.  MD  Christiane  Laue 
    • Schauenburger Str. 116
    • 24118  Kiel
    • Germany
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    • Yakult Europe B.V.
    • Ms.  PhD  Jia  Zhao 
    • Schutsluisweg 1
    • 1332 EN  Almere
    • Netherlands
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Sources of Monetary or Material Support

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    • Yakult Honsha Co., Ltd.
    • 105-8660  Tokyo
    • Japan
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/17
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.