Using tributyrin to prevent complications in acute pancreatitis
Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial
This study is testing if taking tributyrin can help adults with their first episode of acute pancreatitis by improving gut health and reducing complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Delft, South Holland and 1 other locations) |
| Trial ID | NCT06147635 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing their first episode of acute pancreatitis within 24 hours of diagnosis.
Not a fit: Patients with pancreatitis due to ERCP, malignancy, trauma, or those who are immunocompromised will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the severity of acute pancreatitis and its complications, improving patient outcomes.
How similar studies have performed: While the use of tributyrin in this context is novel, previous studies have indicated the potential benefits of short-chain fatty acids in gut health and immune modulation.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Delft, South Holland and 1 other locations
- Reinier de Graaf Gasthuis — Delft, South Holland, Netherlands (Not_yet_recruiting)
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.