Using tributyrin to prevent complications in acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of tributyrin supplementation in patients experiencing their first episode of acute pancreatitis. Participants will be randomly assigned to receive either tributyrin or a placebo (sunflower oil) for 14 days, with the primary focus on measuring changes in plasma endotoxin levels. The study aims to explore the potential immunomodulatory benefits of tributyrin, a pro-drug of butyrate, in improving gut health and reducing complications associated with acute pancreatitis. A total of 92 adult patients will be enrolled in this Phase IIa double-blind randomized placebo-controlled trial.

Why it matters

Who can join: the full rules

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)

Where it's running

• St. Antonius Hospital
  Nieuwegein, Utrecht, Netherlands Recruiting
• Reinier de Graaf Gasthuis
  Delft, South Holland, Netherlands Not yet recruiting

Study contacts

• Principal investigator: H. C. van Santvoort, dr. prof. — St. Antonius Hospital
• Study coordinator: Hannah Pauw, MD
• Email: ha.pauw@antoniusziekenhuis.nl
• Phone: 0883207051

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.