Male and Female, aged 20-64 years Mild constipation (2-4 bowel movements per week) Hard stools, with pain during defecation Mild constipation that has been present for at least 6 months
Conditions
Interventions
2weeks intake of foods containing fermented plant extracts , 4-weeks washout period,2weeks intake of foods no containing fermented plant extract (placebo), Intake three 580mg soft cupsel for 3 times p
Sponsors
Hokkaido Pharmaceutical University School of Pharmacy
Oneness Support Co,.Ltd. Medical Corporation Kaonnkai Miura Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and Female, aged 20-64 years (2)Mild constipation (2-4 bowel movements per week) (3)Hard stools, with pain during defecation (4)Mild constipation that has been present for at least 6 months
Exclusion criteria
Exclusion criteria: (1) Individuals with a serious illness, such as diabetes, brain dysfunction, liver disease, kidney disease, heart disease, peripheral vascular disorders, and digestive system disease or those with a history of such illnesses (2) Individuals currently undergoing treatment for a disease (3) Individuals who have undergone surgery on the digestive tract (4) Individuals with food or drug allergies (5) Individuals routinely using medicinal agents, foods, beverages, or supplements thought to improve constipation (6) Individuals who drink an excessive amount of alcohol daily or who cannot abstain from alcohol on the day before the study (7) Individuals engaged in intense sports or dieting (8) Individuals who are pregnant or who plan to become pregnant or are breastfeeding during the trial period (9) Individuals who have participated in a clinical trial of an investigational drug or a long-term clinical study of a food or cosmetic product (excluding single-dose studies) within the past 4 weeks and individuals who are currently participating in a clinical study (10) Individuals judged as being ineligible to participate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bowel movements, amount of stool, VAS questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of intestinal bacterial flora (as determined by 16S rRNA PCR analysis), type of putrefaction products in feces,Blood test, Urine analysis | — |
Countries
Japan
Contacts
Public ContactKoji Wakame
Hokkaido Pharmaceutical University School of Pharmacy Pharmacology
Outcome results
None listed