Healthy subjects
Conditions
Interventions
Test foods (tablet 250 mg) consumed 1 tablet per day for 8 weeks.
Placebo foods (tablet 250 mg) consumed 1 tablet per day for 8 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females aged 20 to 65 years at the time of informed consent. 2)Persons who are routinely stressed and suffer from diarrhea with abdominal pain and discomfort. 3)Persons who can continuously consume the test food for 8 weeks during the test period. 4)Persons who can visit the medical institution during the study period. 5)Persons who are judged not to be a sick person by an inquiry from a physician. 6)Persons who have received sufficient explanation on the purpose and content of the research, who have the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who have given written consent to participate in the research.
Exclusion criteria
Exclusion criteria: 1)Persons who are currently receiving any drug treatment or ambulatory treatment. 2)Persons who are currently exercising or taking diet under the supervision of a physician. 3)Persons who can't restrict drugs that may affect bowel movements, health foods containing lactobacilli and bifidobacteria, foods for specified health uses, Foods with Function Claims, health supplements, supplements, etc., and foods rich in lactobacilli from the time of acquisition of consent. 4)Patients with gastrointestinal diseases that have an effect on intestinal regulation and who are currently being treated at a medical institution or who have had gastrointestinal surgery (excluding appendectomy). 5)Persons with a history of a disease that is thought to have a major impact on bowel movements. 6)Patients with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 7)Having a history of drug or food allergy. 8)Pregnant or breastfeeder. Those who desire pregnancy and lactation. 9)Persons who can't maintain their usual alcohol intake during the study period. 10)Persons who have donated blood or vaccinated within the past 3 months or scheduled them during the study. 11)Persons with psychiatric disorders or sleep disorders who have a history of psychiatric illness in the past. 12)Alcohol-dependent, drug-dependent, or drug-abused persons who have a history of such treatment. 13)Night workers and shift workers. 14)Persons with irregular habits such as meals and sleep. 15)Persons who have participated in other clinical trials within the past 3 months. 16)Persons who are difficult to record in various questionnaires. 17)Persons who are judged inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Izumo scale, POMS2 abbreviations, blood cytokines (IL-10, IL-6, TNF-a), faecal mucins, and faecal IgAs | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed