A range of individuals from healthy to borderline conditions - Persons with tendency for constipation or diarrhea - Persons classified as normal to 1 degree of obesity - Persons classified with normal to 1 degree of average blood pressure
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Strain TK61406
Dose form / Japanese Medical Device Nomenclature:ORAL SOLUTION
Route of administration / Site of application:ORAL
Dose per administration:2.5
Sponsors
Tokai Pickling Co.,Ltd.
Yasufumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda,Hiroshi Ono
1,Contract Research Organization
Medical Fusion Co.,Ltd.
Hiromichi Hayashi, Yukari Hayashi, Toru Urakawa, Haruka Suminoya
2.Site Management Organization
Medical Fusion Co.,Ltd.
Risa Nakamura, Minami Hotta, Mayu Hotta,Satomi Fuahashi,Saho Kiyooka
3.Clinical trial enforcement medical institution
MEDOC Medical Dock&Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. 1) Men and women aged more than 20 years, and less than 50 years, at the time of giving informed consent. 2) Persons of Japanese nationality, and clear Asian descent. 3) Persons who, during the screening period, are not using chronic or seasonal drugs or medical equipment, and are not undergoing rehabilitation therapy. 4) Persons who have freely given consent and have understood the purpose of the study. 5) Persons with a tendency for constipation or diarrhea. Constipation: More than 2 days of constipation (consecutive or non-consecutive) during the screening period from -7 day to -1 day. Diarrhea: More than 1 day of diarrhea within a period of 2 days during the screening period from -7 day to -1 day. 6) BMI Persons classified as normal to 1 degree of obesity (BMI of less than 30.0 and more than 18.5) based on the "new determination of obesity and diagnostic criteria 2011" of the Japanese Society for the Study of Obesity. 7) Blood pressure Persons whose blood pressure is measured twice in the examination room, and falls in the range of normal to 1 degree of average blood pressure values in adults based on the "hypertension treatment guidelines 2014" of the Japanese Society of Hypertension (systolic blood pressure: less than 159 mmHg, diastolic blood pressure: less than 99 mmHg) 8) Pulse rate 50 - 100 beats/minute 9) Body temperature 35.5 - 37.0 C 10) Persons not participating in excessive exercise 11) Persons not overeating 12) Participants who understand that clinical visits are mandatory during the study period
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to subjects. 1) Persons who have used drugs continuously or occasionally during the screening period from -7 day to visit 0 2) Persons who have the following complications listed in the diagnostic criteria for obesity, based on the "new determination of obesity and diagnostic criteria 2011" by the Japanese Society for the study of Obesity. [Complications] - Impaired glucose tolerance (type II diabetes, impaired glucose tolerance, etc.) - Dyslipidemia - High blood pressure (1 degree of hypertension excluded) - Hyperuricemia, gout - Coronary artery disease, including myocardial infarction, and angina pectoris - Cerebral infarction, including cerebral thrombosis, transient ischemic attack - Fatty liver (non-alcoholic fatty liver disease) - Menstrual abnormalities, pregnancy complications (pregnancy-related hypertension syndrome, pregnancy-related diabetes, dystocia) - Sleep apnea syndrome, obesity hypoventilation syndrome - Orthopedic disease, including osteoarthritis (knee, hip) and deformation of the spine, lower-back pain - Obesity-related kidney disease 3) Persons with gastrointestinal tract, liver, kidney, heart, or circulatory system disease. 4) Persons who have undergone gastrectomy, gastrointestinal suture surgery, or persons with history of major surgery of the gastrointestinal tract, intestinal tract resection, etc., except for polypectomy and appendectomy. 5) Persons with a history of cerebrovascular disease (except asymptomatic lacunar infarction) 6) Persons with tattoos 7) Persons with food allergies, hypersensitivity, or food idiosyncrasies 8) Persons with alcohol or drug dependency. 9) Persons who have participated in other clinical trials within 12 weeks (84 days) of giving informed consent. 10) Persons who have donated 400 ml of blood within 12 weeks (84 days), 200 ml of blood within 4 weeks (28 days), or a blood component (plasma or platelets) within 2 weeks (14 days) of giving informed consent. 11) Persons trying to conceive within the clinical study period. 12) Nursing or pregnant women. 13) Persons whose diagnosis required treatment of mental illness by a clinical investigator. 14) Persons who are unable to comply with administrative matters during the clinical study. 15) Persons who for other reasons are determined to be ineligible by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Safety: primary evaluation items] We will examine the following safety issues in the period from the date of consent to the end of the observational study. 1) Physical signs and symptoms, medical history, current medical history, concomitant medication, combination therapy 2) Body temperature, blood pressure, pulse rate (diastolic blood pressure and systolic blood pressure) 3) Height and weight, body mass index (BMI) 4) Standard 12-lead electrocardiogram 5) Clinical examination (Hematology) White blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, leukocyte count (neutrophils, eosinophils, basophils, monocytes, lymphocytes) (Blood biochemical tests) AST (GOT), ALT (GPT), ALP, LDH, AMY, &gamma-GTP, total protein, albumin, A / G ratio, total bilirubin, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood glucose, BUN, creatinine, uric acid, CPK, serum electrolytes (Na, K, Cl, Ca, Fe, Mg, P) (Urinalysis) Protein, sugar, ketone bodies, urobilinogen, occult blood, pH, specific gravity, pregnancy test in the case of women only (human chorionic gonadotropin) 6) Fecal examination Intestinal bacteria amount ("TK61406", Lactobacillus spp., Bifidobacterium spp., total number of anaerobic bacteria), pH, ammonia content. 7) Defecation status (based on diarizing by subject) Meal status, stool frequency, stool weight, stool properties. 8) Confirmation of adverse events [Efficacy: primary evaluation items] We will examine the efficacy in the period from the date of consent to the end of the observational study. 1) Check the subjects' diaries to evaluate the daily meal situation, stool frequency, stool output, and stool properties. | — |
Secondary
| Measure | Time frame |
|---|---|
| In this clinical study, we will validate the effectiveness of the intervention as a secondary purpose. 1) Fecal examination. Intestinal bacteria content as observed in the feces ("TK61406", Lactobacillus spp., Bifidobacterium spp., total number of anaerobic bacteria), pH, and ammonia content. 2) State of facial skin as examined by Robo Skin Analyzer RSA50. Moisture (moisture value, oil value), color (hue, saturation, brightness), pigmentation, pores, redness, wrinkles (under eyes, crow's feet), granularity 3) Inspection of salivary amylase enzyme reaction after continuous computational load test - Assess the resistance and effectiveness on the central power and by continuous computational load test - Number of Issues (30 questions), the number of digits (2 digits), the calculation method (addition) to unify, assess the number of correct answers and the time taken to produce them - Use the "salivary amylase monitor", Nipro Corporation Medical equipment report number: 27B1X00045000110 general medical devices (class 1) 4) Confirmation of amount of visceral fat and subcutaneous fat by abdominal CT examination 5) BMI (confirmation of obesity level) 6) Blood pressure, pulse 7) Interleukin -12 (IL-12) levels 8) Hematological test White blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, leukocyte count (neutrophils, eosinophils, basophils, monocytes, lymphocytes) 9) Blood biochemical tests AST (GOT), ALT (GPT), ALP, LDH, AMY, gamma-GTP, total protein, albumin, A / G ratio, total bilirubin, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood glucose, BUN, creatinine, uric acid, CPK, serum electrolytes (Na, K, Cl, Ca, Fe, Mg, P) 10) Urinalysis Protein, sugar, ketone bodies, urobilinogen, occult blood, pH, specific gravity | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion CO.,LTD.
Outcome results
None listed