Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged older 20 years or and less than 65 years at the time of the informed consent. 2) Subject who feels stress on a daily basis. 3) Subject who suffering from abdominal ache and diarrhea accompanied by abdominal discomfort. 4) Subject who is judged not to be sick by the doctor's inquiry. 5)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Heavy drinker. 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness (depression) or sleep disturbance. 7)Subject who has irregular work rhythms such as working at night and shift work. 8)Subject who has extremely irregular lifestyle such as eating and sleeping. 9)Subject who has an unbalanced diet. 10)Subject who are currently undergoing treatment for a digestive system disease that affects intestinal function, or who have a history of surgery or history of digestive system disease (Excluding appendectomy). 11)Subject who has or had a history of inflammatory bowel disease, irritable bowel syndrome, or other diseases that are thought to greatly affect bowel movements. 12)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 13)Subject who uses health foods, supplements, and pharmaceuticals that affect bowel function. 14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 15)Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition. 16)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 17)Subject who can't keep the daily records. 18)Subject who is judged as an inappropriate candidate according to the screening data. 19)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Izumo scale | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Defecation survey, special blood test (IL-1beta, IL-6, IL-10, IL-12p70), SF-8 Japanese version, WPAI:GH, intestinal flora test, metabolome analysis (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed