None listed
Conditions
Interventions
Dietary Supplement : 2/day (1 pack), oral before breakfast and dinner
- Schizophyllum commune ß-glucan: 10ml/pack, 20ml/day( ß-glucan 40mg/pack, 80mg/day)
- Placebo: 10ml/pack, 20ml/day
Sponsors
Quegen Biotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged from 19 to 70 years old. 2) Subjects who meet the diagnostic criteria for functional constipation in Roman Standard IV This applies to two or more of the following six items. (However, there is no watery stool or watery diarrhea for the last 3 months, and it should not meet the criteria for diagnosing irritable bowel syndrome) ? If there have been bowel movements less than 3 times a week in the last 3 months. ? If there has been more than 1 out of 4 solidified and lumped bowel movements in the last 3 months. ? If there have been given excessive force to stool in the last 3 months more than 1 out of 4 bowels movements. ? If there has been the feeling of leftover stool after bowel movements in the last 3 months more than 1 out of 4 bowel movements. ? If there has been feeling that the bowel movement has not come out (stool is clogged) during the last 3 months. ? If there has been experience of pressing around the anus or removing the stool with your hand in order to completely see the bowel movement more than 1 out of 4 bowel movements. 3) Subjects who voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this human application test.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs and human testing products 2) Subjects with clinically significant digestive system, rectal anal disease, liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, mental disease, cardiovascular disease, etc. 3) Subjects who meet the criteria for diagnosing irritable bowel syndrome in Roman criteria IV. This applies to two or more of the following three items. (However, there has to be abdominal pain at least once a week on average in the last 3 months.) ? If abdominal pain is related to bowel movements ? If abdominal pain is accompanied by a change in the number of bowel movements ? If abdominal pain is accompanied by a change in stool shape 4) Subjects with a history of gastrointestinal diseases (eg, Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of the test product for human application 5) Subjects who took specialty drugs related to intestinal health within one month from the date of screening test (see Concomitant Drugs) 6) Subjects who have taken herbal medicines or health functional foods related to intestinal health within 2 weeks from the date of screening test 7) Subjects who have received anti-psychotic drug treatment within 2 months from the date of screening test 8) Subjects who participated in other interventional human application tests within 3 months from the date of screening test 9) Subjects who have a history of alcoholism or substance abuse or suspected 10) Subjects who show the following results in the diagnostic laboratory medical examination (AST, ALT> 3 times the upper limit of the normal range, serum creatinine> 2.0 mg/dL) 11) Pregnant or lactating women 12) Women of childbearing potential who are likely to become pregnant and do not accept the implementation of appropriate contraceptive methods (expect for women who have undergone sterilization) 13) Subjects who are judged to be unsuitable for participation in the research due to the results of diagnostic laboratory medical examination and other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut bacteria;Number of Defecation, Bowel movement time, Bristol Stool Scale score, Patient Assessment of Constipation Symptom score, Patient Assessment of Constipation Quality of Life score;Colon Transit Time | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events, Vital sign;Physical examination, Electrocardiogram, Laboratory data;ß-glucuronidase, Short-chain fatty acid, pH, Calprotectin | — |
Countries
Korea, Republic of
Contacts
Public ContactHUI YEON JANG
Jeonbuk National University Hospital
Outcome results
None listed