Healthy Japanese subjects
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged between 20 and 64 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects whose occupancy rate of Bifidobacterium is relatively low
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator (ICD) 3.currently undergoing treatment for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension 4.have chronic constipation 5.have other diseases that may significantly affect bowel movement, or who have a medical history of them 6.have asthma, or may develop asthma during this trial 7.occupancy rate of Lactobacillales order or Bifidobacterium at screening (before consumprion; Scr) is 0% 8.usually use foods containing rich in lactic acid bacteria, or lactic acid bacteria fortified health foods or medicines 9.usually use foods containing rich in Bacillus subtilis var. natto (B. natto), or B. natto fortified health foods or medicines 10.usually use medicines, health foods, "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)" that may affect bowel movement / take ingredients affecting bowel movement (such as dietary fiber) fortified foods 11.usually use or take other FOSHU or FFC 12.currently taking medications (including herbal medicines) and supplements 13.are allergic to medicines and/or the test food related products 14.are day- and night- shift workers / work night multiple times during this trial 15.plan to go abroad during this trial 16.anthropometric measurements, physical examination values or laboratory values markedly deviate from the reference values at pre-consumption test 17.are pregnant, lactation, or planning to become pregnant during this trial 18.suffer from COVID-19 19.have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 20.are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gut microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The state of defecation (numbers of defecation days, defecation frequency, amount of defecation, stool shape, stool color, stool smell, and exhilarating feeling of defecation) 2. Organic acids and intestinal putrefactive products 3. The Japanese Version of the Constipation Assessment Scale Middle Term version (CAS-MT) 4. OSA sleep inventory MA version | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed