A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult
- Conditions
- one
- Registration Number
- JPRN-UMIN000045564
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) Subjects who are under some kind of continuous medical treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine/metabolic system, etc., or have a previous medical history of related serious diseases. (2) Subjects who have drug allergy or severe food one, and/or a previous medical history of those. (3) Pregnant, possibly pregnant, and lactating women. (4) Subjects who are affected by an autoimmune disease. (5) Subjects who have excessive alcoholic drinks. (6) Subjects who are equipped with lactose intolerance constitutionally. (7) Subjects who will take medicine (e.g., antiallergics and antibiotics) during the screening test period, which might affect their immune function, or are taking a specified food containing bifidobacteria, lactic acid bacteria, and so on. (8) Subjects who took part in another clinical study within 28 days before giving informed consent to participate in this study, or are planning to take part in another one during this study. (9) Subjects who donated 400 mL of their blood within twelve weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the screening test period. (10) Subjects who were vaccinated against pandemics such as influenza, novel coronavirus, etc., within a month before prior examination, or are planning to vaccinate them against those viruses before the completion of this study. (11) Others who have been determined as ineligible for the research subject of this study, judging from the principal/sub investigator's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method