Acute PancreatitisPhase 2PARROTNCT06147635
Prophylactic Tributyrin Supplementation in Acute Pancreatitis
A Phase 2 study testing Micro-encapsulated granules of tributyrin (intervention) in people with Acute Pancreatitis, run by St. Antonius Hospital at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Micro-encapsulated granules of tributyrin (intervention)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesNetherlands
- Study dates
- 12 Feb 2024to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Pregnancy and/or lactation
- Age <18 years old
- History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Reinier de Graaf Gasthuis
Delft, South Holland, 2625AD
Rutger Quispel, dr. MD., 0152603089 ext. +31, r.quispel@rdgg.nl
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Hjalmar C. van Santvoort, Prof. dr., 0883201942 ext. +31, h.van.santvoort@antoniusziekenhuis.nl
Hannah Pauw, drs., 0623559868 ext. +31, ha.pauw@antoniusziekenhuis.nl
About this study
Official title: Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement 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.
Read the detailed description
Rationale: Acute pancreatitis (AP) is a common gastrointestinal disorder requiring acute hospitalization. Around 20% of patients that present with acute pancreatitis eventually develop severe complications such as (multiple) organ failure, (peri-) pancreatic necrosis, and secondary infections (i.e. infected necrosis, bacteraemia, pneumonia). The gut, especially the gut microbiome, is likely to play a role in development of infectious complications. Short-chain fatty acids (SCFAs) produced by the gut microbiota, such as butyrate, are known immunomodulators of the host response and exert local beneficial effects on the gut barrier and microbiota. Currently, there are no safe and effective therapies to mitigate disease severity that can be administered in the early phase of pancreatitis. We hypothesize that orally administered tributyrin, a pro-drug of butyrate, might beneficially influence disease progression in acute pancreatitis and may be useful as prophylaxis.
Objective: The main objective is to investigate the effect of oral tributyrin on plasma endotoxin in patients with acute pancreatitis after 3 days of treatment.
Study design: Phase IIa (Proof of concept) double-blind randomized placebo-controlled food supplement trial.
Study population: 92 adult patients with a first episode of acute pancreatitis.
Intervention: The intervention group receives three times daily 4g micro-encapsulated granules of tributyrin and the control group receives three times daily an equivalent volume of micro-encapsulated vegetable oil (i.e. placebo), for a total of maximum 14 days.
Main study parameters/endpoints: The primary endpoint is plasma endotoxin concentration after 3 days of tributyrin treatment. Secondary endpoints include toxicity, clinical outcomes, intestinal permeability, fecal SCFA concentrations, intestinal microbiota composition and systemic inflammatory response parameters (pulse, respiratory rate, temperature and white blood cell count).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The blood sampling at inclusion, and day 3 and 7 of treatment are preferably combined with regular blood sampling. Participants may experience minor discomfort from rectal swabs. Phase 1 studies with oral tributyrin conducted in patients with solid tumors did not report serious adverse events. However, there is a risk of unanticipated adverse events in our target population. An independent data safety and monitoring board (DSMB) will discuss all reported serious adverse events (SAE's).
- Conditions
- Acute Pancreatitis
- Being tested
- Micro-encapsulated granules of tributyrin (intervention), Micro-encapsulated granules of sunflower oil (placebo)
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-encapsulated granules of tributyrin (intervention)Dietary supplement
Three times daily 4 grams of micro-encapsulated granules of tributyrin, for a maximum of 14 days
Micro-encapsulated granules of sunflower oil (placebo)Dietary supplement
Three times daily 4 grams of micro-encapsulated granules of sunflower oil, for a maximum of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Micro-encapsulated tributyrin granules, 4 grams three times daily, for a maximum of 14 days Receives: Dietary Supplement: Micro-encapsulated granules of tributyrin (intervention) |
| Control group | Placebo comparator | Micro-encapsulated sunflower oil granules, 4 grams three times daily, for a maximum of 14 days Receives: Dietary Supplement: Micro-encapsulated granules of sunflower oil (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma endotoxin levels
Plasma endotoxin levels
Measured: Measured 3 days after randomisation
Secondary outcomes (15)
Mortality
Occurence of death
Measured: During the whole study period including follow-up of 90 days
Infectious complications
The occurence of infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, and/or infected ascites
Measured: During the whole study period including follow-up of 90 days
(New onset) transient/persistant (multiple) organ failure
The occurence of (new onset) transient/persistant (multiple) organ failure
Measured: During the whole study period including follow-up of 90 days
Disease severity according to the revised Atlanta Classification
Disease severity according to the revised Atlanta Classification
Measured: During the whole study period including follow-up of 90 days
(Peri-)pancreatic necrosis
The occurence of (peri)pancreatic necrosis
Measured: During the whole study period including follow-up of 90 days
Length of hospital and/or ICU stay
Measured in days
Measured: During the whole study period including follow-up of 90 days
The need (and number of) for surgical, endoscopic or radiologic interventions
The need (and number of) for surgical, endoscopic or radiologic interventions
Measured: During the whole study period including follow-up of 90 days
Fecal and saliva microbiota and fecal metabolomics (i.e., SCFAs) analysis
Fecal and saliva microbiota and fecal metabolomics (i.e., SCFAs) analysis
Measured: During the whole study period including follow-up of 90 days
Readmissions
The occurrence and number of readmissions
Measured: During the whole study period including follow-up of 90 days
Systemic inflammatory response parameters (SIRS): pulse
Pulse measured in beats per minute
Measured: During the initial admission
Systemic inflammatory response parameters (SIRS): respiratory rate
Respiratory rate measured in breaths per minute
Measured: During the initial admission
Systemic inflammatory response parameters (SIRS): temperature
Temperature measured in degrees celsius
Measured: During the initial admission
Systemic inflammatory response parameters (SIRS): white blood cell count
White blood cell count
Measured: During the initial admission
Exocrine insufficiency
Exocrine insufficiency
Measured: During the whole study period including follow-up of 90 days
Endocrine insufficiency
Endocrine insufficiency
Measured: During the whole study period including follow-up of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start12 Feb 2024
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HC van Santvoort, St. Antonius Hospital
- Investigators
- H. C. van Santvoort, dr. prof., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147635
- Sponsor's protocol ID
- NL81496.100.22
- Acronym
- PARROT
- Status last verified
- Feb 2024
- First submitted
- 10 Jul 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial
- ClinicalTrials.gov ID
- NCT06147635
- Acronym / sponsor ID
- PARROT / NL81496.100.22
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Acute pancreatitis (AP) is a common gastrointestinal disorder requiring acute hospitalization. Around 20% of patients that present with acute pancreatitis eventually develop severe complications such as (multiple) organ failure, (peri-) pancreatic necrosis, and secondary infections (i.e. infected necrosis, bacteraemia, pneumonia). The gut, especially the gut microbiome, is likely to play a role in development of infectious complications. Short-chain fatty acids (SCFAs) produced by the gut microbiota, such as butyrate, are known immunomodulators of the host response and exert local beneficial effects on the gut barrier and microbiota. Currently, there are no safe and effective therapies to mitigate disease severity that can be administered in the early phase of pancreatitis. We hypothesize that orally administered tributyrin, a pro-drug of butyrate, might beneficially influence disease progression in acute pancreatitis and may be useful as prophylaxis.
Objective: The main objective is to investigate the effect of oral tributyrin on plasma endotoxin in patients with acute pancreatitis after 3 days of treatment.
Study design: Phase IIa (Proof of concept) double-blind randomized placebo-controlled food supplement trial.
Study population: 92 adult patients with a first episode of acute pancreatitis.
Intervention: The intervention group receives three times daily 4g micro-encapsulated granules of tributyrin and the control group receives three times daily an equivalent volume of micro-encapsulated vegetable oil (i.e. placebo), for a total of maximum 14 days.
Main study parameters/endpoints: The primary endpoint is plasma endotoxin concentration after 3 days of tributyrin treatment. Secondary endpoints include toxicity, clinical outcomes, intestinal permeability, fecal SCFA concentrations, intestinal microbiota composition and systemic inflammatory response parameters (pulse, respiratory rate, temperature and white blood cell count).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The blood sampling at inclusion, and day 3 and 7 of treatment are preferably combined with regular blood sampling. Participants may experience minor discomfort from rectal swabs. Phase 1 studies with oral tributyrin conducted in patients with solid tumors did not report serious adverse events. However, there is a risk of unanticipated adverse events in our target population. An independent data safety and monitoring board (DSMB) will discuss all reported serious adverse events (SAE's).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Micro-encapsulated granules of tributyrin (intervention)Micro-encapsulated tributyrin granules, 4 grams three times daily, for a maximum of 14 days |
| Control group | Placebo comparator | Dietary Supplement: Micro-encapsulated granules of sunflower oil (placebo)Micro-encapsulated sunflower oil granules, 4 grams three times daily, for a maximum of 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
- Pregnancy and/or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intervention group |
| 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 | Dietary supplement | Control group |
Primary outcome
Plasma endotoxin levels
Time frame: Measured 3 days after randomisation
Plasma endotoxin levels
15 secondary outcomes
Mortality
Time frame: During the whole study period including follow-up of 90 days
Infectious complications
Time frame: During the whole study period including follow-up of 90 days
(New onset) transient/persistant (multiple) organ failure
Time frame: During the whole study period including follow-up of 90 days
Disease severity according to the revised Atlanta Classification
Time frame: During the whole study period including follow-up of 90 days
(Peri-)pancreatic necrosis
Time frame: During the whole study period including follow-up of 90 days
Length of hospital and/or ICU stay
Time frame: During the whole study period including follow-up of 90 days
The need (and number of) for surgical, endoscopic or radiologic interventions
Time frame: During the whole study period including follow-up of 90 days
Fecal and saliva microbiota and fecal metabolomics (i.e., SCFAs) analysis
Time frame: During the whole study period including follow-up of 90 days
Readmissions
Time frame: During the whole study period including follow-up of 90 days
Systemic inflammatory response parameters (SIRS): pulse
Time frame: During the initial admission
Systemic inflammatory response parameters (SIRS): respiratory rate
Time frame: During the initial admission
Systemic inflammatory response parameters (SIRS): temperature
Time frame: During the initial admission
Systemic inflammatory response parameters (SIRS): white blood cell count
Time frame: During the initial admission
Exocrine insufficiency
Time frame: During the whole study period including follow-up of 90 days
Endocrine insufficiency
Time frame: During the whole study period including follow-up of 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
H. C. van Santvoort, dr. prof. principal investigator
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micro-encapsulated granules of tributyrin (intervention) in people with Acute Pancreatitis, run by St. Antonius Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Pauw, MD (0883207051 ext. +31, ha.pauw@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma endotoxin levels (time frame: Measured 3 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.