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RECRUITING
NCT06147635
PHASE2

Prophylactic Tributyrin Supplementation in Acute Pancreatitis

Sponsor: St. Antonius Hospital

View on ClinicalTrials.gov

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.

Official title: Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2024-02-12

Completion Date

2027-01

Last Updated

2024-06-20

Healthy Volunteers

No

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

Locations (2)

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands