Prophylactic Tributyrin Supplementation in Acute Pancreatitis

Launched by ST. ANTONIUS HOSPITAL · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a supplement called tributyrin in patients who are experiencing their first episode of acute pancreatitis, which is a sudden inflammation of the pancreas. The main focus of the study is to see how taking tributyrin affects the level of certain harmful substances in the blood, known as endotoxins. Participants in the trial will be randomly assigned to one of two groups: one group will take tributyrin three times a day for 14 days, while the other group will take a placebo, which is a harmless substance that looks like the supplement but doesn't have any active ingredients.

To participate in this study, individuals must be adults aged 18 or older who are diagnosed with their first episode of acute pancreatitis within the last 72 hours. They should also be able to understand the study and give their consent. However, those with certain conditions, like pancreatitis caused by specific procedures or certain health issues, as well as pregnant or nursing individuals, are not eligible. Overall, this trial is an important step in understanding whether tributyrin might help patients with acute pancreatitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)