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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000019264 |
Receipt No. | R000022246 |
Scientific Title | 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. |
Date of disclosure of the study information | 2015/10/07 |
Last modified on | 2015/10/07 |
Basic information | ||
Public title | 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. | |
Acronym | Effect of daily ingestion of Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine. | |
Scientific Title | 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. | |
Scientific Title:Acronym | Effect of daily ingestion of Lactobacillus gasseri SBT2055 on antibody response to influenza vaccine. | |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To prove the clinical benefits of daily ingestion of yogurt drink containing Lactobacillus gasseri SBT2055 on antibody response to influenza vaccines for 16 weeeks. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Antibody titers to influenza vaccine |
Key secondary outcomes | Natural 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Ingestion of 100g of yogurt drink containing Lactobacillus gasseri SBT2055 daily for 4 weeks prior to influenza vaccination and for 12 weeks after vaccination. | |
Interventions/Control_2 | Ingestion of 100g of yogurt drink without Lactobacillus gasseri SBT2055 daily for 4 weeks prior to influenza vaccination and for 12 weeks after vaccination. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Subjects who plan to get inoculated with influenza vaccine in the current financial year.
2.Subjects who agree to participate in the current study with written informed consent. |
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Key exclusion criteria | 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. |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido Information University | ||||||
Division name | Department of Medical Management and Informatics | ||||||
Zip code | |||||||
Address | 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan | ||||||
TEL | 011-385-4411 | ||||||
nishihira@do-johodai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido Information University | ||||||
Division name | Health Information Science Center | ||||||
Zip code | |||||||
Address | 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan | ||||||
TEL | 011-385-4430 | ||||||
Homepage URL | |||||||
nishihira@do-johodai.ac.jp |
Sponsor | |
Institute | Hokkaido Information University |
Institute | |
Department |
Funding Source | |
Organization | MEGMILK SNOW BRAND Co., Ltd , Milk Science Research Institute |
Organization | |
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Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道情報大学 保健センター(北海道) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022246 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
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