A verification study on improvements in the immune system and defecation: A randomized open-label trial
- Conditions
- Japanese adults who are healthy or regularly see a doctor
- Registration Number
- JPRN-UMIN000028269
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Shimono T, Hoshino T, Takahashi Y, Takara T. Synbiotics Containing Bifidobacterium longum BB536 improve bowel movements and enhance immunity in elderly people-A randomized, open-label, parallel-group study-. Jpn Pharmacol Ther. 2020; 48(7): 1167-1177
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 93
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. Those who take laxative tablets 10. Those who are currently taking supplements 11. Those who are allergic to medicines and/or the test food related products 12. Those who are pregnant, breast-feeding, and plan to become a pregnant 13. Those who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 14. 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. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *Assess at 0 and 4 weeks after consuming
- Secondary Outcome Measures
Name Time Method 1. Subjective symptoms a. Bristol Stool Scale b. Bowel movement diary c. The Likert scale method * Above a and c, assess at 0 and 4 weeks after consuming * Above b, record when defecating 2. Immunity test T lymphocyte age, Immunological age, number of T cells, number of CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, NK cells, and CD8+CD28+T cells, T-cell proliferation index, number of CD4+T cells, CD8+T cells and memory T cells *Assess at 0 and 4 weeks after consuming 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