Effects of consumption of the food containing lactic acid bacteria on the intestinal environment in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048456
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method