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Prophylactic Tributyrin Supplementation in Acute Pancreatitis

NCT06147635 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Micro-encapsulated granules of tributyrin (intervention)

Three times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days

DIETARY_SUPPLEMENT

Micro-encapsulated granules of sunflower oil (placebo)

Three times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • H. C. van Santvoort, dr. prof. · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147635 on ClinicalTrials.gov