Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Capsule containing killed lactic acid bacteria Administration: Take one capsule twice daily (morning and night, in total two capsule a day) with water without chewing
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. Adults 4. Healthy subjects 5. Subjects whose defecation frequency for a week prior to Scr is 10 times or more and 20 times or less 6. Subjects whose defecation frequency which stool shape are classified as "slightly loose stool (5)" or "muddy stool (6)" in the Bristol stool scale are 50% or more of the total defecation frequency for a week prior to Scr
Exclusion criteria
Exclusion criteria: Subjects who 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 3.have treatment for chronic diseases such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension 4.usually take "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)" 5.are currently taking medicines (including herbal medicines) and supplements 6.are allergic to medicines and/or the test food related products 7.are pregnant, lactating, or planning to become pregnant during this trial 8.suffer from diarrhea 9.have had diarrhea for at least 2 weeks prior to agreeing to participate 10.meet the diagnostic criteria for irritable bowel syndrome (IBS)* or have already been diagnosed with IBS *Recurrent abdominal pain on average at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: 1) Related to defecation, 2) Associated with a change in frequency of stool, 3) Associated with a change in form (appearance) of stool (Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis) 11. have diseases that may substantially affect bowel movement 12.usually take foods containing rich in lactic acid bacteria (LAB), or health foods or medicines fortified with LAB (e.g., yogurt, drink, or supplements) 13.usually take medicines, health foods, FOSHU, or FFC that may affect bowel movement/take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles, and foods fortified with dietary fiber) 14.take alcohol exceeding 20 g per day 15.have lactose intolerance 16.have been enrolled in other clinical trials within 28 days before agreeing to participate or plan to participate another trial during this trial 17.are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period 5* * Period 5: The 4th week after consumption of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period 2, 3, and 4* 2. The number of defecation days and amount of defecation in period 2, 3, 4, and 5* 3. Each classification of stool shape, stool color, stool smell, and exhilarating feeling of defecation in period 2, 3, 4, and 5* 4. The subjects whose defecation frequency in period 5* is five times or more and nine times or less 5. The subjects whose defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 5 <Definition> The number of "slightly loose stool" or "muddy stool" in period 5 / The defecation frequency in period 5 x 100 < 50 6. The subjects whose defecation frequency in period 5* is five times or more and nine times or less, and defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 5 7. The Gastrointestinal Symptom Rating Scale (GSRS) (total score, Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation), the Izumo Scale (total score, each subscale (heartburn, gastralgia, postprandial fullness, constipation, diarrhea)), the rate of water content in stool, and the intestinal flora at four weeks after consumption (4w) * Period 1: Seven days prior to screening (before consumption: Scr) Period 2: The 1st week after consumption of the test food Period 3: The 2nd week after consumption of the test food Period 4: The 3rd week after consumption of the test food Period 5: The 4th week after consumption of the test food | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed