Effect of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine in healthy adult volunteers: a randomized, double-blind, placebo-controlled, parallel group comparison study.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000019264
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Not provided
1.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine or metabolic disorders or affected with an infectious disease which is required to report to the authorities. 2.Subjects who are suspected to have acute infection such as influenza, etc. 3.Subjects who are under treatment for chronic inflammatory diseases, autoimmune diseases or allergies, etc. 4.Subjects who were vaccinated within 12 weeks prior to participating this study. 5.Subjects who have had anaphylactic reaction, etc. to influenza vaccine in the past. 6.Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries. 7.Pre- or post-menopausal women having complaints of obvious physical changes. 8.Subjects with unusually high or low blood pressure, or with abnormal hematological data. 9.Subjects with serious anemia. 10.Subjects with a history of allergy to medicine or food (especially dairy products, eggs or chicken meat). 11.Subjects who regularly take drugs which may affect the immune function Chinese herbal medicine, health food or supplements (mushrooms, seaweed, nucleic acids, yeast, lactobacillus, etc.) 12.Subjects who regularly take drugs for constipation or diarrhea. 13.Subjects who regularly take the products such as "Megumi Yogurt" "Megumi Drink Type" "Megumi 0 Fat" or other yogurt products from Megumi series of MEGMILK SNOW BRAND Co., Ltd. 14.Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 15.Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood component within 2 weeks prior to this study. 16.Subjects who are pregnant or expected to be pregnant, or lactating during the study. 17.Subjects who participate in other clinical trials within the last one month prior to this study. 18.Any other medical reasons judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibody titers to influenza vaccine
- Secondary Outcome Measures
Name Time Method atural Killer cell activity , leukocyte differential count, flow cytometric lymphocyte subset analysis , salivary sIgA, MIF, urinary 8-OHdG, produced IFN- alpha /beta by PBMC, expression level of antiviral mRNA in PBMC, proliferative capacity of T cells, frequency of occurrence of cold-like symptoms, plasma IgG and IgA