Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis
Not Applicable
- Conditions
- Clostridium difficile enteritis
- Registration Number
- JPRN-UMIN000026874
- Lead Sponsor
- Osaka City University
- Brief Summary
Four transplants were performed, and data collected. After that, due to the COVID-19 epidemic, no more cases were enrolled and the study was terminated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have malignant tumors or serious systemic diseases (central nervous disease, psychiatric disorders) or poor general condition 2) Patients who already have gastrointestinal disease.(i.e. Crohn's disease, intestinal tuberculosis) 3) Patients who have swallowing disorder 4) Patients who have severe liver disease (AST or ALT >=100 IU/L) 5) Patients who have severe kidney disease (serum Cre >= 2.0 mg/dL) 6) Pregnant or lactating women 7) Patients who are judged by doctors as inappropriate as subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rate of Clostridium difficile enteritis within 6 months Incidence of adverse events due to fecal microbiota transplantation (FMT)
- Secondary Outcome Measures
Name Time Method Improvement of intestinal microflora before and after fecal microbiota transplantation therapy