Actively Recruiting
Prophylactic Tributyrin Supplementation in Acute Pancreatitis
Led by St. Antonius Hospital · Updated on 2024-06-20
92
Participants Needed
2
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prophylactic Tributyrin Supplementation in Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First episode of acute pancreatitis
- Able to read and/or understand the study procedures
- Able to give informed consent (or their legal representatives)
- Less than 24 hours after diagnosis of acute pancreatitis
- Less than 72 hours after onset of symptoms of acute pancreatitis
You will not qualify if you...
- Pancreatitis caused by endoscopic retrograde cholangiopancreatography, malignancy, or trauma
- Post-operative pancreatitis
- Intra-operative diagnosis of pancreatitis
- Immunocompromised patients including those on chemotherapy, radiotherapy, long-term or high-dose immunosuppressive treatment, or with illnesses like AIDS, leukemia, or lymphoma
- Pregnancy or breastfeeding
- Younger than 18 years old
- History of recurrent or chronic pancreatitis according to MANNHEIM criteria
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625AD
Not Yet Recruiting
2
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Actively Recruiting
Research Team
H
Hannah Pauw, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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