Japanese adults who are healthy or regularly see a doctor
Conditions
Interventions
Duration: 4 weeks Test Material: Probiotic food (high dose) Dosage: Take 1 pack, three times a day after each meal
Duration: 4 weeks Test Material: Probiotic food (low dose) Dosage: Take 1 pack, o
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sixty-five years and more Japanese adults who have 2-5 times of defecation per week 2. Those who are considered as appropriate for the study by the physician 3. Above 2, priority selective those who have high CAS scores in CAS-MT at screening and pre-ingestion
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *Assess at 0 and 4 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed