Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group
Completed
- Conditions
- Acute pancreatitisDigestive System
- Registration Number
- ISRCTN38327949
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Patients of all Dutch University Hospitals and major non-University Hospitals who are admitted with predicted severe acute pancreatitis.
Added Feb 2008:
1. Age equal to or above 18 years
2. First episode of acute pancreatitis
3. Written and oral informed consent
Exclusion Criteria
Added Feb 2008:
1. Post-ERCP pancreatitis
2. Malignancy
3. Infection/sepsis caused by a second disease
4. Intra-operative diagnosis
5. Immunocompromised patients
6. Use of probiotics during admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total number of infectious complications.
- Secondary Outcome Measures
Name Time Method 1. Costs<br>2. Hospital stay<br>3. Intesive care unit (ICU) stay<br>4. Mortality<br>5. Morbidity