chronic constipation
Conditions
Interventions
Sponsors
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:
Exclusion criteria
Exclusion criteria: 1, Patients who have bristol score 1 or 7 2, Patients who have fewer than one defecation per week 3, Patients who have obvious defecation disorders 4, Patients who have fewer than one of overall JPAC-QOL score 5, Patients who are excluded mechanical disorders by colonoscopy within five years 6, Patients who have severe complications 7, Patients who have history or current evidence of celiac disease or inflammatory bowel disease 8, Patients who are under treatment with steroid or biological products 9, Patients who have severe psychiatric disease 10, Patients who have current evidence of abuse of drugs or alcohol 11, Patients who have history of bifidobacteria allergies 12, Patients who had taken new drug therapy within 4 weeks before entry 13, Patients who had any change in types, dosage,or adiministration of their prescribed drugs within 4 weeks before entry 14, Patients who or are going to take new medicines 15, Patients who or are going to be participating in other clinical studies 16, Patients who are under treatment with other probiotics 17, Patients who are judged as inadequately for study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in JPAC-QOL score from pre-to after 8 weeks intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1,The comparison of JPAC-QOL score between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study) 2,The comparison of stool form,degree of sense of incomplete evacuation,degree of straining and frequency of internal use of rescue drugs between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study) 3, The change in profile of gut microbiome from pre-to after 8 weeks drug intervention 4,The drug compliance 5,The incidence rate of adverse events | — |
Countries
Japan
Contacts
Public ContactFuyuki Akiko
Yokohama City University school of medicine Department of gastroenterology and hepatology
Outcome results
None listed