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Prophylactic Tributyrin Supplementation in Acute Pancreatitis

RecruitingPhase 2Ages 18 Years - anyAllSt. Antonius Hospital
NCT06147635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Micro-encapsulated granules of tributyrin (intervention)
  • Micro-encapsulated granules of sunflower oil (placebo)
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Where

2 sites
Reinier de Graaf Gasthuis
Delft, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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