Recruiting PHASE2 Acute Pancreatitis

New treatment option for Acute Pancreatitis

Official title Prophylactic Tributyrin Supplementation in Acute Pancreatitis

ClinicalTrials.gov ID: NCT06147635

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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...
  • Pregnancy and/or lactation
  • Age \<18 years old
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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...
  • Pregnancy and/or lactation
  • Age \<18 years old
  • History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)

The study team makes the final eligibility decision.

Where it's taking place

  • Delft, South Holland, Netherlands
  • Nieuwegein, Utrecht, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Delft, South Holland, Netherlands; Nieuwegein, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.