Chronic Constipation Irritable Bowel Syndrome with Constipation (IBS-C) Functional Constipation (FC)
Conditions
Interventions
Fruit Extract 54g per day for 8 weeks
Placebo drink 54g per day for 8 weeks
Sponsors
Oneness Support Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and Female, aged 20-75 years (2)Subjects who have subjective symptoms of constipation (Gastrointestinal Symptom Rating Scale;GSRS) (3)Subjects who have less than three bowel movements per week or fall under the Bristol Stool Form Scale 1 or 2 (4)Constipation symptoms occur more than six months ago and have symptoms for the last three months (5)Subjects who has written consent for participation in the study
Exclusion criteria
Exclusion criteria: (1)Subjects with a history of diabetes, cirrhosis, chronic hepatitis, renal failure, heart failure, cerebral infarction, cerebral hemorrhage, myocardial infarction, angina pectoris, a history of cancer, or a history of surgery of the digestive system (esophagus, stomach, duodenum, small intestine, large intestine, rectal rectal, gallbladder, pancreas) (2)Subjects who have been pointed out abnormalities in liver function and renal function test values in the last three months (3)Subjects who currently have a disease under treatment (4)Subjects with fruit allergies (5)Subjects who have taken either acid secretion inhibitors, antibiotics, or laxatives within the past three months (6)Subjects who are consuming excessive alcohol (7)a pregnant person, or a subject who is expected to become pregnant or breast-feeding (8)Subjects who are participating in other clinical trials or scheduled to participate in the trial or are less than three months after the end of the trial (9)Subjects with cold symptoms within the past month (10)Subjects diagnosed with new coronavirus from within the past three months (11)Subjects judged inappropriate by the doctor responsible for the examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel Movement (0, 4, 8w) Bristol Stool Form Scale (0, 4, 8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of intestinal bacterial flora (0, 4, 8w) Stool metabolome analysis (0, 4, 8w) Gastrointestinal Symptom Rating Scale (GSRS) (0, 4, 8w) Subjective indicator survey (0, 4, 8w) | — |
Countries
Japan
Contacts
Public ContactTaishi Koyama
Miki Corporation Institure for Health science
Outcome results
None listed