A study to evaluate the effects of Biofermin tablets on bowel management in elderly patients requiring long-term care
- Conditions
- Constipation
- Registration Number
- JPRN-jRCTs031210287
- Lead Sponsor
- Maruyama Michio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
The elderly over 65 years old.
Patients who cannot defecate by themselves,requiring defecation assistance.
Patients who can take nutrition and drugs orally or by tube at the time of enrollment.
Patients who have less than 3 spontaneous bowel movements per week during the pre-observation period.
Patients who receive defecation treatment or additional laxatives at least once a week during the pre-observation period.
Patients who can provide the written consent for participation in this study. However,if the consent cannot be obtained by the patient,it is possible to obtain consent from a legally acceptable representative.
Patients who have been pointed out to have organic abnormalities in the digestive tract.
Patients with serious complications.
Patients with infectious diseases.
Patients with active malignant tumors.
Patients who are allergic to intestinal medicine.
Patients who took probiotic products within two weeks before enrollment.
Patients who took opioid analgesics within two weeks before enrollment.
Patients who have been using psychiatric drugs for the treatment of psychiatric disorders, except for the use of sleeping pills or psychotropic drugs as needed.
Patients who took antibacterial agents within two weeks before enrollment.
Patients who started the new drug administration within two weeks before enrollment.
Patients who are inadequate to be enrolled in the study judged by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method