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Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38327949
Enrollment
200
Registered
2004-07-14
Start date
2004-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis Digestive System Acute pancreatitis

Interventions

Patients are randomly assigned to receive either live multispecies probiotics (6 strains, Ecologic 641) or placebo for 4 weeks by nasojejunal tube. Treatment is started within 72 hours after onset of

Sponsors

University Medical Centre Utrecht (UMCU) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Total number of infectious complications.—

Secondary

MeasureTime frame
1. Costs 2. Hospital stay 3. Intesive care unit (ICU) stay 4. Mortality 5. Morbidity—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026