Healthy subjects
Conditions
Interventions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 20 to less than 65 at the time of written informed consent. 2.Subjects who have a tendency toward chronic constipation with 2 to 4 bowel movements per week. 3.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects diagnosed with constipated by a physician. 2.Subjects with brain disease, malignancies, immune disease, diabetes mellitus, liver disease (hepatitis), kidney, heart, thyroid, adrenal, and metabolic diseases, and subjects who currently have or previously had serious manifestations of these conditions. 3.Subject receiving medication or outpatient treatment for a serious disease. 4.Subjects who regularly consume medicines, supplements, or health foods that support the regulation of intestinal function, or foods rich in components that may influence the regulation of intestinal function, such as lactic acid bacteria, bifidobacteria, oligosaccharides, or dietary fiber. 5.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics ,or subjects who plan to take such medication during the test period. 6.Subjects who are at risk of having allergic reactions to drugs or foods. 7.Subjects with current or previous history of drug dependence or alcohol dependence. 8.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more). 9.Subjects receiving exercise or diet therapy under the supervision of a physician. 10.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 11.Subjects whose eating, sleeping, and other habits are extremely irregular. 12.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.) , or who has a history of mental illness in the past. 13.Subjects who are having a very unbalanced diet. 14.Smoker 15.Subjects who are currently pregnant or lactating, may become pregnant during the study period. 16.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of bowel function (defecation frequency, number of defecation days, fecal output) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Evaluation of bowel function (defecation questionnaire (stool consistency, stool color, stool color, post-defecation feeling)), Evaluation of Intestinal Flora (16S rRNA Gene Analysis), extracellular water ratio, Visual analog scale (swelling, skin, QOL) (Safety evaluation) Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed