NCT06147635 Prophylactic Tributyrin Supplementation in Acute Pancreatitis
| NCT ID | NCT06147635 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Antonius Hospital |
| Condition | Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2024-02-12 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
H. C. van Santvoort, dr. prof.
PRINCIPAL INVESTIGATOR
St. Antonius Hospital
Frequently Asked Questions
Who can join the NCT06147635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06147635 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06147635 currently recruiting?
Yes, NCT06147635 is actively recruiting participants. Contact the research team at ha.pauw@antoniusziekenhuis.nl for enrollment information.
Where is the NCT06147635 trial being conducted?
This trial is being conducted at Delft, Netherlands, Nieuwegein, Netherlands.
Who is sponsoring the NCT06147635 clinical trial?
NCT06147635 is sponsored by St. Antonius Hospital. The principal investigator is H. C. van Santvoort, dr. prof. at St. Antonius Hospital. The trial plans to enroll 92 participants.