Prophylactic Tributyrin Supplementation in Acute Pancreatitis
Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial
St. Antonius Hospital
92 participants
Feb 12, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is: • The effect of oral tributyrin supplementation on the plasma endotoxin level Participants will be randomized between two groups: intervention and control group. They will receive: \- three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. placebo), for a total of 14 days In total 92 adult patients with a first episode of acute pancreatitis will be included.
Eligibility
Inclusion Criteria5
- First episode of acute pancreatitis (AP)
- Able to read and/or understand the study procedures
- Able to give informed consent (or their legal representatives)
- <24 hours after diagnosis of AP
- <72 hours after onset of symptoms of AP
Exclusion Criteria7
- Pancreatitis due to endoscopic retrograde cholangiopancreatography (ERCP), malignancy or 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 <18 years old
- History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)
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Interventions
Three times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days
Three times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06147635