A study for evaluating the effect of the intake of a lactobacillus-containing food on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate : randomized, placebo-controlled, double blind trial
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000018423
- Lead Sponsor
- TTC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Subjects who routinely use (more than 3 times a week) food or medicine containing of lactobacillus 2) Subjects routinely taking dietary supplements which may influence immune function 3) Subjects who has history of the allergic disease 4) Subjects who are under medication which may influence the outcome of the study (e.g., hyposensitization) 5) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 6) Subjects who has oral or dental problems with bleeding 7) Night and day shift worker or manual laborer 8) Subjects who has carries out an intense activity (e.g., marathon race) 9) Subjects who cannot carry out a procedure of various inspection by the rule during the study period 10) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 12) Subjects having possibilities for emerging allergy related to the study 13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 17) Subjects who are judged as unsuitable for the study by the investigator for other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Salivary s-IgA secretion rate
- Secondary Outcome Measures
Name Time Method Salivary s-IgA concentration