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

Not Applicable

• Conditions: Enhancement of influenza vaccination effect; J10; Influenza due to identified seasonal influenza virus

• Registration Number: DRKS00003958
• Lead Sponsor: Yakult Honsha Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-04-17
• Study Start: 2012-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 638

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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