A placebo-controlled, double-blind, randomized, comparative superiority trial concerning subjective physical symptoms effected by taking lactic acid bacteria in healthy adults.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000051260
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Not provided
1.Those who are undergoing treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system, etc., or those who have a serious history of these. 2.Those who have or have a history of drug allergies or serious food allergies. 3.Those who are pregnant or breastfeeding, or willing to be pregnant during the trial period. 4.Those who have autoimmune diseases. 5.Alcohol drinking over 40g/day (nearly equal to 2 medium-sized beer bottles) more than 3 days per a week. 6.Those who use drugs that are thought to affect immune function including antiallergic drugs and antibiotics, or who regularly use foods containing specific bifidobacteria, lactic acid bacteria, etc. However, those who can stop after obtaining consent can participate. 7.Those who have participated in other clinical trials within 4 weeks before the date of the consent obtained, or those who plan to participate during the trial period. 8.Those who have collected 400 mL or more of blood within 4 weeks before the consent obtained, or 200 mL or more of blood was collected before the date of pre-intake examination after the consent obtained. 9.Those who have been vaccinated against infectious diseases such as influenza and novel coronavirus within 4 weeks before the day of the pre-ingestion inspection. 10.Those who are judged by the investigator to be unsuitable as a study participant based on the results of study participant background, physical findings, medical examination, physical examination, clinical examination, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective symptoms related to physical condition
- Secondary Outcome Measures
Name Time Method Immunological functions