acute pancreatitis
Conditions
Interventions
The intervention group receives three times daily 4g micro-encapsulated
granules of tributyrin and the control group receives three times daily an
equivalent volume of micro-encapsulated vegetable o
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: acute pancreatitis, defined as two or more of the following criteria: - abdominal pain - serum amylas or lipase more than three times the upper limit - evidence of acute pancreatitis on abdominal CT
Exclusion criteria
Exclusion criteria: -Pancreatitis due to ERCP, malignancy, trauma -Post-operative pancreatitis -Intra-operative diagnosis -Immunocompromised patients (history or current immunosuppressive treatment such as chemotherapy, radiotherapy, longer use of immunosuppressive medication or recent high doses, immunocompromised illness* such as AIDS, leukemia, lymphoma) -Pregnancy and/or lactation -Age 72 hours since onset of symptoms - Episode of acute pancreatitis within the last year, or a history of three or more episodes of acute pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is plasma endotoxin concentration measured 3 days after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are toxicity, clinical outcomes, intestinal permeability, fecal SCFA concentrations, intestinal microbiota composition and systemic inflammatory response parameters (pulse, respiratory rate, temperature and white blood cell count), response of peripheral blood mononuclear cells (PBMCs) to stimulation with LPS, capacity of PBMCs to phagocytose/kill bacteria (E. coli). | — |
Countries
Netherlands
Contacts
Public ContactR. B. Schwarz
St. Antonius Ziekenhuis
Outcome results
None listed