Prophylactic Tributyrin Supplementation in Acute Pancreatitis
ConditionAcute Pancreatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Antonius Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Micro-encapsulated granules of tributyrin (intervention)
Dietary supplementThree times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days
Micro-encapsulated granules of sunflower oil (placebo)
Dietary supplementThree times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plasma endotoxin levels
Plasma endotoxin levels
Time frame
Measured 3 days after randomisationSecondary outcomes
1
Mortality
Occurence of death
Time frame
During the whole study period including follow-up of 90 days2
Infectious complications
The occurence of infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, and/or infected ascites
Time frame
During the whole study period including follow-up of 90 days3
(New onset) transient/persistant (multiple) organ failure
The occurence of (new onset) transient/persistant (multiple) organ failure
Time frame
During the whole study period including follow-up of 90 days4
Disease severity according to the revised Atlanta Classification
Disease severity according to the revised Atlanta Classification
Time frame
During the whole study period including follow-up of 90 daysSponsors and contacts
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Source ClinicalTrials.gov