A verification study on improvements in the immune system and defecation: A randomized open trial
- Conditions
- Japanese adults who are healthy or regularly see a doctor
- Registration Number
- JPRN-UMIN000026387
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Shimono T, Hoshino T, Takara T. Effects of an Oral Nutritional Supplement Drink Containing Lactobacillus paracasei MCC1849 on Improving the Immune System of Elderly People-A Randomized Open-label Trial-. Jpn Pharmacol Ther. 2019; 47(1): 97-113
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Not provided
1. Those who have the medical history or under the treatment of malignant tumor 2. Those who have the medical history or under the treatment of autoimmune disease 3. Those who have the medical history or under the treatment of inflammatory bowel disease 4. Those who are currently hospitalized 5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 6. Those who eat Natto, yogurt, and food and beverage including lactic acid bacteria in daily 7. Those who are smokers 8. Those who take anti-allergic drugs 9. Currently taking supplements 10. Those who are allergic to medicines and/or the test food related products 11. Those who are pregnant, breast-feeding, and plan to become a pregnant 12. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 13. Others considered as inappropriate for the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Scoring of immunological vigor *Assess at 0 and 4 weeks after consuming
- Secondary Outcome Measures
Name Time Method 1. Immunity test T lymphocyte age, Immunological age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD8+CD28+T cells, T-cell proliferation index, CD4+T cells, CD8+T cells, memory T cells *Assess at 0 and 4 weeks after consuming 2. Subjective symptoms a. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) b. Bristol Stool Scale c. Bowel movement diary d. The Likert scale method *Above a, b, and d, assess at 0 and 4 weeks after consuming *Above c, record when defecating 3. Saliva test Salivary immunoglobulin A (sIgA) *Assess at 0 and 4 weeks after consuming 4. Blood test High-sensitive CRP, albumin, prealbumin *Assess at 0 and 4 weeks after consuming 5. Physical examination Muscle mass, grip strength *Assess at 0 and 4 weeks after consuming