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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Reinier de Graaf Gasthuis
NOT_YET_RECRUITING
Delft
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Hannah Pauw, MD
ha.pauw@antoniusziekenhuis.nl
0883207051
Time Frame
Start Date: 2024-02-12
Estimated Completion Date: 2027-01
Participants
Target number of participants: 92
Treatments
Experimental: Intervention group
Micro-encapsulated tributyrin granules, 4 grams three times daily, for a maximum of 14 days
Placebo_comparator: Control group
Micro-encapsulated sunflower oil granules, 4 grams three times daily, for a maximum of 14 days
Sponsors
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov